There is often a disconnect in toxicity assessment between what is reported on clinical trials as being “well tolerated” and the lived experience of taking a treatment for patients. Toxicity minimizing language including “safe” and “tolerable” are subjective and can downplay quality of life limiting side effects from treatment. A recent paper published in JCO OP reported that less than half of phase 3 clinical trials had “complete” toxicity reporting including total adverse events, deaths, and discontinuation due of toxicity. Dr. Chino welcomes two guests to discuss patient-centered clinical trial design with a focus on side effect profiles of treatment.

TRANSCRIPT

Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

There is often a disconnect in toxicity assessment between what is reported on clinical trials as being, quote-unquote, "well tolerated" and the lived experience of taking a treatment for patients. Toxicity-minimizing language includes words like "safe" and "tolerable." They are subjective and can downplay quality of life–limiting side effects from treatment. A recent paper published in JCO OP reported that less than half of phase 3 clinical trials had complete toxicity reporting, including total adverse events, deaths, and discontinuations due to side effects.

I'm overjoyed to welcome two guests to the podcast today to discuss patient-centered clinical trial design with a focus on side effects from treatment.

Dr. Ethan Ludmir is an Assistant Professor at MD Anderson Cancer Center with a primary appointment in GI radiation oncology. He is a prolific researcher on topics encompassing clinical trials, cancer outcomes, and the integration of biostatistics in oncology. He has a specific interest in improving clinical trial design, including designing patient-centered endpoints and complete reporting. He led collaborators in the manuscript that will frame our discussion today called, "Incomplete Toxicity Reporting and the Use of Toxicity-Minimizing Language in Phase III Oncology Trials," which was published earlier this year in JCO OP.

Stacey Tinianov is the executive director and co-founder of Advocates for Collaborative Education, a global advocacy organization uniting patient, research, and policy advocates through pan-cancer collaborations, basic and advanced advocacy education, and the sharing of leading practices to change the narrative in cancer outcomes. Following her diagnosis and treatment for early-stage breast cancer 12 years ago, Stacey  has become a leading national voice for patient advocacy and empowerment via collaborative education, community building, shared decision-making, health data access, and person-centered design.

Our full disclosures are available in the transcript of this episode, and we've already all agreed to go by our first names for the episode today.

Ethan and Stacey , it's wonderful to speak to you.

Dr. Ethan Ludmir: Terrific. Thank you so much for having us, Fumiko. It's a pleasure to be here with friends and colleagues of many years to be able to talk about this important topic.

Stacey Tinianov: Yes, thank you. Delighted to be invited, delighted to be part of the conversation.

Dr. Fumiko Chino: Our specific topic today is toxicity minimization, either by underreporting or by language and framing that downplays the lived experience of treatment. Ethan, do you mind starting us off by telling us how you got interested in toxicity reporting and then briefly discussing what your study team did and the findings?

Dr. Ethan Ludmir: Absolutely. Thank you, Fumiko. I have the privilege and luxury of being able to present research that is 100% the brainchild and terrific work of colleagues and friends, including the first author, a terrific graduate student named Avi Miller; colleagues like Alex Sherry. So I think it's always important to acknowledge I'm here mostly for window dressing. They really did the lion's share of the work and really have reported this fascinating story.

Our lab works primarily on issues related to the optimization of clinical trial design and reporting. One of these key topics that has come up more and more over the course of time is how are we presenting toxicities? And so we gave this project the sort of cute name of "The Table 3 Fallacy." Right? When you present a clinical trial report, usually Table 3, just by the way things end up getting numbered, is generally where you find these toxicities. You see a massive Excel sheet of reported toxicities, and invariably it ends up kind of culminating in a sort of pithy couple of sentences saying, "Toxicity was manageable."

So we wanted to really drill down on this with sort of two features in mind. One of them was, how well are we doing at objectively reporting physician-assessed toxicity? And of course, that comes with the itinerant kind of limitation that all three of us have both written about and talked about, that is physician-assessed toxicities are very different than patient-experienced toxicities - and maybe we'll put that to a side for one second - but objective toxicities on one hand and then subjective characterization of those toxicities on the other.

So for this project, we looked at, we've sort of cultivated over the years an actively updated database of every phase 3 trial that's been completed in clinicaltrials.gov since the website's inception. And so in this report, we looked at over 400 trials representing over 300,000 patients enrolled. And we wanted to assess objectively how many trials reported in their manuscripts serious adverse events, treatment-related deaths, study therapy discontinuation, and an emerging area that really bears some emphasis, which is reporting of lower-grade toxicities. And I know we're going to discuss this as this moves forward, but especially in the last few years, this has entered visibility as an area that we really ought to be emphasizing more. As a sort of anecdotal point, it's very easy to characterize a single grade 3 episode of toxicity that potentially is self-limited. But on the other hand, if you've got a patient who has the misfortune of having grade 2 nausea day in and day out - sure, that's grade 2, but that can be much more impactful on somebody's quality of life. So being cognizant of these kinds of differences is important.

So we went through these 400 trials and objectively categorized using pre-established guidelines how many reported serious adverse events, treatment-related deaths, study therapy discontinuation. And the answer is only 44% of trials consistently do this. We added and created sort of our own guideline - everyone comes up with guidelines these days, so we said we're going to do our own guideline - and add into the mix reporting of lower-grade toxicities. And if you call "complete toxicity reporting" doing what's been done before and reporting lower-grade toxicities, then only 32% of trials report out these complete toxicities.

And perhaps the most interesting covariate there is that our industry-supported trials, which increasingly dominate the scene, those tend to do a better job at reporting toxicity profiles than cooperative group–sponsored studies. And we can kind of dissect that, perhaps, on the back end.

And the final point is we looked at how often investigators are using language like, "Study therapy had toxicity that was acceptable or tolerable." These subjective languages that fundamentally minimize the experienced toxicities. And the answer is nearly half of trials report- have that language in the study text itself, often in the discussion section or the abstract. And this is what's picked up, right? This is what our patients read. This is what news outlets read. And I think this really fundamentally undermines a lot of the nuances here. But if you let me keep talking, I'll just keep talking forever, so I'll stop talking.

Dr. Fumiko Chino: That was a really excellent summary of what your team did, and I agree 100%. Give credit where credit is due. It is a whole team that brings research like this to publication, and so I really always respected the fact that you have worked in very large teams and have given due credit to people like trainees along the way that are doing some really elegant work under the auspices of the- I'll just call it ‘The Ludmir Lab’.

Now, as you mentioned, patients may really consider side effect profiles very differently than what investigators determine could be, quote-unquote, "clinically relevant." Stacey, I'd really love your take on the toxicity topic and how you've seen this play out in both the advocacy space and in your role as a scientific advisor.

Stacey Tinianov: First of all, I am truly thrilled that all of this is being examined. We know that words matter. We know that we've managed to change our collective language in the oncology space and our understanding significantly of that impact in the last 10 years. We've modified phrases like, you know, "patients failing treatment" and we've moved to what is kind of more “what actually failed patients”. So, you know, I think the key piece there is when we describe things like "manageable" and "tolerable" in scientific publications or in that Table 3, we are looking at “clinically relevant". And so I want to acknowledge that when you talk to people in clinic, you know, "manageable" means that there's a way to clinically manage a side effect. "Tolerable" means that treatment can continue. So we understand where these phrases originated from. However, as Ethan mentioned, these terms have very different meanings in day-to-day living.

I spent some time actually quite recently at the FDA talking about the gratitude I have that, you know, safety and efficacy is a primary concern for the FDA because as advocates and certainly as patients, we care about safety and efficacy. But we also are incredibly concerned with quality of life, and it's particularly important to say because all of these great therapies are only great therapies if individuals can stay on them. And if these so-called "manageable" and "tolerable" side effects, as they start to accumulate, people have to come off treatments, well then all of that incredibly hard work and all of those resources to bring something to market are for naught.

The other thing I think it's highly dependent on individuals, and I think that, again, when we quantify and when we, you know, qualify something, we have to do it kind of in a population setting. And yet I think we need to acknowledge that all individuals are different, and something that may truly be "manageable" and/or "tolerable" in one individual might not be in another. And so I think we need to make room for that. And the reason the language is so important is so we can make those choices. We can weigh the benefits to the risks, not just on a cellular level, but on an impact level. So again, so excited to have this conversation.

Dr. Fumiko Chino: I love that personal take on it, which is that it is personal. You have your own experiences, obviously, with toxicities, but that individuals may not be comparable across each other and aggregate number on a spreadsheet is very different than lived experience.

Stacey Tinianov: When you look at those hundreds of thousands of individuals, those were the cancer Olympians. Those were the individuals that qualified for a clinical trial because even though they were sick and in some cases very, very, very sick, they were the best of the best. And so that toxicity profile is on a population that has actually made it into a clinical trial. But once a drug is approved and once it's put into market, it's potentially available to anybody, and so we see those side effects, you know, sometimes in a much more complicated situation. But too, you know, again based on the individual, even if this drug gets out and it's the same diarrheagenic profile for one individual as another, the impact of that on a quality of life is very, very different. Somebody who really enjoys sitting outside and birdwatching and hanging out with friends and reading books, as long as they’re within ten feet of a bathroom, the diarrheagenic effects of a drug are going to impact that person probably far less than somebody who rates their quality of life on how many summits they can peak.

Dr. Fumiko Chino: 100%. I can even say for my own lived experience, when my father-in-law received cancer treatment, they actually chose one of his treatments based on the fact that he is a guitar player, and so they really wanted to minimize his risk of peripheral neuropathy. And so, you know, instead of cisplatin, they chose cetuximab for his treatment, even though it is maybe suboptimal in a straight numbers comparison, but the toxicity was very meaningful.

Now, there was another recent JCO OP study published this year focusing on patients with melanoma on immunotherapy. It found that of the 70% of patients with any toxicities, about half of them were, quote-unquote, "only" grade 1 or 2. But in this so-called "low-grade toxicity," 15% were hospitalized, 31% had treatment stopped because of toxicity, 33% needed to go on an immunosuppressive medication. Now, Ethan, do you mind putting this into perspective from the kind of clinician and clinical trialist standpoint?

Dr. Ethan Ludmir: With pleasure. And this is a terrific piece and really highlights and informs a lot of the reasons that complete toxicity reporting is crucial. Right? We need to know about the grade 1-2 side effects because invariably, as much as we like to relegate those to second-class status in how we've to date been characterizing physician-reported toxicities, clearly, there's a dramatic impact in many of those toxicities on people's ability to tolerate therapy, their ability to require additional intervention like immunosuppressives, and it's really quite central in the way we think about things.

The other facet, I think, that's increasingly relevant here is the treatment discontinuation aspect of things is one that increasingly from a statistical perspective comes to the fore. We've written about this before in a couple of different pieces, but it's something that I'm not always sure gets enough billing, which is that study therapy discontinuation is often not considered an event. And so when you design Kaplan-Meier curves and you report these out, those patients are censored rather than marked as having an event. And so you get weird statistical effects of how those curves are perceived because you're almost ignoring the folks who had the toughest time with the therapy when those are among the most informative patients when you're thinking about things from both a large-scale regulatory perspective to Stacey 's point, and again to Stacey's point, the individual in front of you.

So I mean, it's a terrific piece of work and also speaks to, as we think about the era of PROs really getting more and more mature in how we analyze them and integrate them into our trials, it also speaks to the challenges of just objectively quantifying toxicity from a physician perspective as tick mark “That is one grade 3 toxicity.” Can we make this multidimensional? Are we thinking more about the time perspective? How long is the grade 2 toxicity going for? Are you having a day of nausea or continuous nausea for a month? These are the things that I think are relevant as we think about optimization of our endpoints going forward.

Dr. Fumiko Chino: Patient-reported outcomes has entered the chat. I love it.

Now, Stacey, do you have anything to add from a patient perspective?

Stacey Tinianov: I absolutely do, and I think the discontinuation piece is critical. But again, I also want to add that once things get approved and are in market, it's not a digital discontinuation or continuation. We have, obviously, dose reductions that tend to be led by clinical expertise. But what we're seeing in the community, especially with some of these newer targeted therapies, is individuals medicate themselves. For instance, diarrhea, you know, fatigue, there's a lot of very, very clinical side effects, but I think diarrhea is the one I like to focus on because I don't think I've ever talked to anybody who has not experienced diarrhea. So I think there's a level of understanding and empathy there. But when we look at some of these diarrheagenic, especially in the CDK4/6 space, we have individuals who, one, because it's manageable and tolerable, are given an over-the-counter prescription for an antimotility drug, and that drug then causes another side effect, and this side effect isn't measured. This is not in the toxicity profile of a therapeutic. It's in the toxicity profile of the supportive care medication. And so what we're seeing is this incredible cascading effect of diarrhea, constipation, diarrhea, constipation, diarrhea. And so patients say, "You know what, enough is enough. I'm about to go on a vacation. I'm going to take two weeks, and I'm not going to take my meds." And whether they communicate to their doctor or not probably depends a lot on their relationship. But from a drug standpoint, with these drugs, we don't know what that does, right? And so we know that we have people not taking the therapy as it was intended and approved, and this is directly a result of the side effects.

The other piece is, I think it's important to note that when we think about side effects, I think oftentimes we think about a finite period of time, but some individuals are on drugs forever. They're on it forever until it stops working. And so, if you say that, okay, fatigue is really, really a challenge, but if it's your new regular, you're never going to feel better than this, that's a really hard decision to make.

The other piece is, again, I think that when we think about these grade 1 and these grade 2 side effects, we don't necessarily visualize what that actually means. And so going back to poop, because we all like talking about poop, you know, a grade 2 side effect - and one of the things you already know - is defined as four to six loose, watery stools as baseline. So one of my favorite conversations or favorite phrases or questions, I guess, is to say, “You know, just take a second. Where in your busy day would you put four to six extra loose, watery stools?” And then, you know, you're like, "Oh my gosh, that's not tolerable." So it really is just this like huge, huge, huge consideration for people, and I'm not saying that these drugs shouldn't be on the market, but what I am saying is when you publish the results of how these drugs affect individuals, that needs to be part of the conversation so it can be part of the shared decision-making.

Dr. Fumiko Chino: 100%, 100%.

Now, Stacey  and I both just returned from ASCO 2025, where the so-called "latest and greatest" new treatments were showcased. There were at least a handful of times where I heard that X new treatment was both efficacious and tolerable without any patient perspective presented. And it's been over four years since I heard the incredible Jill Feldman speak about the importance of patient-reported outcomes, including her famous slide highlighting the difference between how you look and how you feel. Stacey, you've been in the advocacy space for over a decade. Do you think we're making any progress over time on this issue?

Stacey Tinianov: I should probably lead with the fact that I am an optimist. So my answer, my answer is ‘yes’. And I mentioned earlier that I've watched the focus on words and and our language is starting to change based on the recognition that words matter. I think for the most part we don't call individuals who decide to join clinical trials, we don't call them ‘subjects’ anymore. We're recognizing them as humans. We're also incredibly excited about what is starting to be presented on the main stage. I know that, you know, at this past ASCO, we had, you know, many individuals who were on stage as advocates in conjunction with the luminaries in the clinical and the research space. And so I think that's progress because I don't think there's one advocate who wasn’t on stage to kind of share, you know, some of these similar concerns.

But we're also seeing it in the research space itself. So Advocates for Collaborative Education decided that quality of life was something that was not being well studied and not being well represented. So a couple of years ago, we actually did an advocacy-led study, "More Than a Diagnosis: A Quality of Life Survey for Individuals with a History or Diagnosis of Cancer.” We did it because we knew it needed to exist. We also created our own survey because the current validated measurement tools that look at quality of life, one, they're administered by a clinician, right, so you're not necessarily getting that- they're not necessarily looking at the things that we as patients care about. So we created this survey with patients and with advocates. And the most exciting thing is once we accrued - we had 516 responses across a variety of cancers, and we did this in a matter of five weeks - and we submitted abstracts to SABCS, to ASCO, to ASCO Quality, and we've had posters or presentations at every one. We are talking about these words "manageable" and "tolerable," but more importantly, I think we're talking about being able to integrate quality of life into the decision-making process in clinic and also integrate quality of life into how we evaluate from a patient-reported outcomes standpoint in the clinical trials. And so it's a process. I recognize it's a process, and I also recognize for those who are struggling now, it is moving too slowly. But ultimately, and I know the three of us can agree, when choosing cancer therapies, people should not have to choose between being alive and living. So living, really, really living is what we're focused on.

Dr. Fumiko Chino: Absolutely. I would say quality of life and quantity of life are both equally important. Ethan, do you have anything to add to what Stacey  just eloquently said?

Dr. Ethan Ludmir: Candidly, she framed it exactly the way I would want to if I were more eloquent myself. So no, I think that's exactly where we're at. I live in my own little pond of statistics, so a lot of things that I'm worried about deal with how we're measuring quality of life, how we're analyzing it. The devil is usually in the details there, but on one hand, like, that's something I feel is a direction that, kind of behind the curtain, the statistic- statisticians really have to do a lot of work and education to get there. But in a certain way, that's a much easier challenge than what both of you are describing now as we see sea change at the level of who's talking at ASCO, who's being brought into the conversation and trial design, whose voices are being heard and propagated. So I think the math is much easier to work out than the vision. And so kudos to both of you for spearheading that vision and seeing it realized, I think, in real time, which must be very, very rewarding.

Dr. Fumiko Chino: I've been so enthused about how many patient advocates I've seen on both big ASCO and then, of course, ASCO Quality, the health services meeting. I know that at least the session that I had at ASCO had a patient advocate as a speaker. So I think, again, our sort of ideal world is that every single session has a patient advocate to help frame the research and the data from the perspective of the lived experience of someone on cancer treatment or a survivor of cancer.

Stacey Tinianov: It's so important for me to acknowledge that none of that would have happened without people like you that are embracing it. We recognize, advocacy recognizes that we needed champions on the inside to be able to come in and share those perspectives. We so, so recognize that. So, thank you for that.

Dr. Fumiko Chino: We have a mole in ASCO, and it's a patient-centered mole. Thank you for that.

All right, switching tack just a little bit for our last little bit of the podcast. Ethan, I know you've been on really a mission to improve clinical trial design and really have a growing body of meta-research or, you know, "research about research." Why is meta-research important, and how do we learn from it to refresh and reinvigorate clinical trials so that they provide better information to providers but also more meaningful outcomes to patients?

Dr. Ethan Ludmir: That's a terrific question. A little bit loaded in the life and times in which we live right now, but a terrific question. So I think clinical trials are fascinating. I think there's tremendous avenues of opportunity in how we design them, how we execute them, how we interpret them, how we analyze them. So that gets me up in the morning. That really puts a skip in my step. I love JCO OP. I will put in the very smallest of plugs for a different journal in which we just published a report two days ago that was presented concurrent at ASCO on how many clinical trials in the last 25 years have actually moved the needle in quantity of life or quality of life. And I know all three of us can share this perspective, you know, each with different words, but at the end of the day, that's what matters. We need to know that whatever we're doing, we're improving somebody's quality of life, their quantity of life, or ideally both. And so my trainees kind of hear me say this repeated often and often and often. And I think it's very important because in many ways, for a little while now, we've lost the thread at the regulatory level, at the sponsor level, and that's nothing new. There's a lot of ink that has been spilled about this. But the beauty of meta-research in a certain way, and to be clear, I'm a clinical trialist in my day job too, and I think there's a key role of not just being there and being an armchair quarterback, but then living it yourself and running your own trials and having to work with sponsors and partners, ensuring that you involve patient advocates and hearing their voices, not just ticking a box off on a checklist.

Meta-research gives us this separate avenue to really sort of think about things, trying to see the forest through the trees. What really does evidence-based medicine show us? Where are we doing well? Where are we not doing well? There's a tremendous body of literature that, in our small way, we've contributed to some of those conversations, and we're incredibly proud as a group about that.

But especially in an era and a time when the structure of evidence-based medicine is being called into question, the validity of evidence is being called into question, I think in many ways, it is easy to be on an extreme. It is easy to take a flag and plant it on a hill and say, "I believe X or I believe Y," and the other side, another view, is completely wrong. And as I tell my trainees, many of these people are also in that meta-research space, and I try to spend a lot of effort to say, we might not get the flashiest headlines, and a lot of journals, and I'm very grateful that JCO OP is not among this number, will specifically want papers that are almost trying to be inflammatory. And we very much want to paint an even-handed picture. Here's what we're doing well, here's what we suck at, here's how we can move forward. Do you make changes through editorial policies or regulatory policies? Do you make changes just by, as both of you have done, keeping that conversation alive, using the media and the forums you have at your disposal to just say, "This is something we need to be talking about more and focusing on"?

And I think the the important thing that I carry forward, especially as we see changes at the regulatory and the administrative levels, are that use the data in front of you, analyze them with integrity, present them with integrity, and say, "Here's what we're doing well, here's what we're not doing well, here's the believability of our data, here's where we think we're weak." And invariably, the truth is somewhere in the middle. President Eisenhower said, "The middle is a very lonely place to be," but invariably, it's right. And I'm definitely butchering that quote, so you'll forgive me, but that's very much kind of how I think we should be approaching things, is that even-handed, "What are we doing well? What do we need to work on? And how do we find the right partners to get us there?"

Dr. Fumiko Chino: Absolutely. I know that Dr. Sherry, who presented that research you mentioned that was simultaneously published in JAMA Oncology, relayed the research showing that very few trials are powered to an overall survival benefit and so they're not showing that. Very few trials are showing a quality of life benefit, and even fewer than few trials are showing both an overall survival and a quality of life endpoint. What was striking to me is that one of the people who came up to the microphone said something along the lines of, "Well, if you have this, you don't need to measure quality of life," and I was like, "Hold me back," because quality of life no matter what is one of the most important endpoints. If you live two months longer but it's in pain, I'm not sure what the living is. I say this as a cancer widow.

Now, Stacey , anything to add given your role as a patient advisory for new treatment testing, for development, for patient education? Anything to add? I know you have an opinion about this.

Stacey Tinianov: Well, I have opinions about a lot of things. But I want to, you know, thank you for bringing up the divisiveness that exists, and I think that the divisiveness that exists in society is obviously impeding our work. But in advocacy, we're there for every individual, and we're there to advocate for the best possible outcomes and the best possible experience for every individual. And cancer's incredibly nondiscriminatory. It really doesn't matter if you're a, "I did my own research," or if you're kind of leaning into evidence-based medicine. And so I don't know that I live in the middle, but I definitely think that there's a lot of value in being the bridge. Just sitting in the middle and observing, I think, maybe it's just not enough action for me, but really trying to figure out what are the things that we can agree on. I think we can agree on quality of life. I think we can agree on ‘we need to do better.’

I will say I'm excited because I do feel like things are changing. And again, change is hard and sometimes change is slow. But we do have groups, you know, the Patient-Centered Dosing Initiative, a group that was started by a few metastatic breast cancer patients that said, "You know what? We are overdosing people," and we kind of know that because the way we approve drugs is to get to the maximum tolerated dose, a little over, and then pull back. That's where we then go through the rest of everything else. So of course these toxicities are high. I, and I can’t quote the source, but this week, I learned that approximately 1% of payload in some of these large ADCs actually gets through. And a lot of that depends on, you know, how much is going to be able to filter through, but what that means is we are giving such a high load that of course these toxicities are high. And so I think the more we know, the more we can address. There will be situations where it is what it is and people will just need to decide what's right for them.

But I think from a clinical trial standpoint, I think, you know, again I'm preaching to the proverbial choir here, advocacy and helping making trial designs, trial protocols much more friendly to the individual who's going to sign up, it's a win-win for everybody because we're going to be able to accrue. We're going to actually be able to do the research and we're going to be able to get people who understand why they're participating, what the potential benefits and risks are, and that's going to really help with reducing the attrition rate. It's really going to help with people who are committed to making sure that we can see this through. So I love this. I think, you know, a goal for me is to see more lay summaries on our research. I think let's communicate what we're doing and the impact of what we're doing so that the rest of - on both sides of this bridge - so that the rest of society has a better understanding.

Dr. Fumiko Chino: One thing that you said really stuck at me as a treating physician is that I've had patients on, let's just say a CDK4/6 inhibitor, who really were underplaying their toxicity to their medical oncologist because they did not want to get a dose reduction. And I have to be, "You know what, on that clinical trial," I have it here, "70% of the people on the clinical trial, the Olympians of clinical trial participation, they needed a dose reduction, and we still get this benefit from 70% of those people had a dose reduction." So it is okay for you to have a dose reduction as well. And I, you know, I have to emphasize that to patients fairly frequently how important it is to balance the what you're getting out of it and what it's putting you through.

Stacey Tinianov: With regard to that, and I think that's a fantastic topic, the way that dose reduction is often communicated and especially communicated in meetings like ASCO and all the other meetings, is it's de-escalation. And de-escalation, it's a technical term, and it also, especially to individuals who are new to the oncology space and new to treatment, it feels like they're getting less than. You're de-escalating, you're getting less than. And so I think when it's framed as "right-sizing," "Yes, this drug was approved in a population, and right now what we're doing is we're right-sizing it for you as an individual," I think the comfort level in individuals is much, much higher for that. So, and I know you do because I know you.

Dr. Fumiko Chino: That's funny. As a radiation oncologist, we're constantly de-escalating. I put that in quotes, but I have shifted it to “right-sizing” more recently because I think I might have heard you say that, and I thought, "Well, that is actually great language, and it's very patient-centered language."

As we wrap up our time on this podcast, I want to just give a little bit of space at the end. Is there anything that we missed, any large topic that is uncovered, or any last thoughts before we close out? Ethan, anything from you?

Dr. Ethan Ludmir: I echo Stacey entirely. I think there's a tremendous opportunity space, even in today's slightly politically charged environment, to be robust and earnest in our research, to maintain continuously the focus on patients, right-sizing rather than de-escalating, talking about toxicities in a meaningful and appropriate way, understanding the validity of not only the results for the individual but now taking again a big step back, the results at the population level, the results for clinical trial populations, and the general population.

As much as we live through chaotic times and and these are tough times, I think this is in certain ways an important opportunity for us to continue focusing on what matters. And I remain just as Stacey, ever the optimist, that we're going to maintain the positive direction, address the things that we need to address. And sometimes I always feel a little guilty writing papers like this because the purpose is not to say that we're doing something wrong or bad, but rather, here are areas of easy, layup opportunities for improvement. And I think those remain sort of the important things to keep in mind, even in a divisive environment. There are easy ways to bring everyone again back together and improve where we're at.

Stacey Tinianov: So well said, Ethan, and I just want to acknowledge that everything that happens in this conversation and kind of the larger academic medical world, we need to be having these conversations in community because we were just with 44,000 of our closest friends in Chicago, but how many other thousands and thousands of oncology professionals, advocates, and patients were not in the room and actually won't actually receive any of this information for potentially years. So as we start to think about how we can right-size and reorient in the clinical trials space and in the reporting space, we also need to be thinking how we can start to right-size and reorient in clinical care, not only in these large academic medical centers that are so plugged in, but in these smaller rural community settings where, I promise you, they're having the same adverse event experiences, just maybe not as wonderfully supported.

Dr. Fumiko Chino: It's a great way of ending the podcast. Thank you so much for this wonderful conversation today. Many thanks to both Dr. Ethan Ludmir and Dr. Tinianow, as well as our listeners for your time today.

You will find the links to the papers that we have discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope that you will join us next month for Put into Practice's next episode. Until then, I encourage you to think deeply before saying that a treatment was "well tolerated."

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Conflicts of Interest

Fumiko Chino

Employment

Company: MD Anderson Cancer Center

Consulting or Advisory Role

Company: Institute for Value Based Medicine

Research Funding

Company: Merck

Stacey Tinianov

Consulting or Advisory Role

Company: Blue Note Therapeutics

Company: ARTIDIS

Company: Napo Pharmaceuticals

Travel, Accommodations, Expenses

Company: ARTIDIS

Company: Napo

Ethan Ludmir

Employment

Company: Alaunos Therapeutics

Recipient: An Immediate Family Member

Honoraria

Company: Nanobiotix

Consulting or Advisory Role

Company: Xerient

Frustrations regarding the costs and difficulties with parking at hospitals is a common concern voiced by patients, families, and healthcare providers. Transportation barriers to receiving cancer care are incredibly common despite what appears to be relatively straightforward solutions. Dr. Chino welcomes two patient-centered health policy experts to discuss this: Dr. Arjun Gupta, MBBS, an Assistant Professor at the University of Minnesota; and Dr. Shakira Grant, MBBS, MSCR, the Founder & CEO of CROSS Global Research & Strategy.

Dr. Fumiko Chino: Hello, and welcome to Put Into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an assistant professor in radiation oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

Frustrations regarding the costs and difficulties with parking at hospitals are some of the most common concerns voiced by patients, families, and healthcare providers online. There is nary a topic where you'll find a more unified level of outrage. Transportation barriers to receiving cancer care are incredibly common, despite what appears to be a relatively straightforward solution—to parking costs, at least.

To discuss this, I'm excited to welcome two patient-centered health policy experts as guests today. Both have published work in JCO OP about transportation barriers.

Dr. Arjun Gupta, MBBS, is an assistant professor at the University of Minnesota. He is a gastrointestinal oncologist, a symptom management enthusiast, and a health services researcher. His research examines cancer care access and delivery, the cost of cancer care, and the hidden burdens imposed on and faced by people with cancer and their caregivers while receiving this care. His 2020 editorial, "Park the Parking," documented parking costs at the top US hospitals as a source of financial toxicity.

Dr. Shakira Grant, MBBS, MSCR, is the founder and CEO of CROSS Global Research and Strategy, a boutique consultancy focused on advancing equity-centered strategic solutions to complex healthcare challenges at the local, national, and global levels. She is the former health policy advisor to the US House of Representatives Ways and Means Health Subcommittee. Prior to that, she was an assistant professor at the University of North Carolina. Her qualitative analysis was published earlier this year and is called "Paying to Be a Patient in the Hospital and the Parking Lot: Patient-Caregiver Dyad Perspectives on Health-Related Transportation Access in Multiple Myeloma."

Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today.

Arjun and Shakira, it's exciting to speak with you today.

Dr. Arjun Gupta: Thank you. It's a joy to be here, Fumiko.

Dr. Shakira Grant: Thank you so much for having me also.

Dr. Fumiko Chino: Our specific topic today is transportation barriers to receiving optimal cancer care. This concern fits within the larger focus of addressing the social determinants of health, with the goal of improving access to high-quality cancer care for all. Research on health-related social risks and needs has proliferated in the last decade, and recent evaluations of food, housing, and transportation insecurity have expanded our knowledge on the barriers that some people face to receive care.

Arjun, do you mind starting us off with just a bit of background about why these issues matter for patients?

Dr. Arjun Gupta: Sure. So, just some background on social determinants of health. These are non-medical factors that are often at the community level that can have direct impacts on both health and health outcomes. So, these are all the issues that are associated with living and our daily lives: where we live, where we work, do we play, and what we play. All of these issues can, of course, impact what sort of medical conditions one might develop, but also the medical care that one might be able to receive.

And we think about someone who does have access to public transportation or does have access to a private vehicle, for example, or someone who is a daily wage earner or an hourly wage earner, or someone who lives next to a toxic wasteland and is exposed to chemicals. So, all of these factors can, of course, influence our health risks. And as one can imagine, all of these social determinants of health can lead to health risks or social risks.

And so, my real interest in this topic came about when I was a first-year oncology fellow. So much of our training in residency is on the inpatient side. But when we had our own continuity clinic in oncology during my first year of fellowship is when I realized the importance of parking and transportation for the first time. When a patient who was receiving FOLFOX chemotherapy for colon cancer, I asked them if they wanted to get blood work a couple of days before chemotherapy so that they wouldn't have to wait for the blood work to result on the day of chemotherapy, and they very passionately said, "Oh, of course not. I only want to come in one day because the parking costs $12, and Christmas is coming up, and I need to buy presents for my grandkids." And that really, really struck me.

I remember reaching out to you, Fumiko, at that time. We were junior investigators and launching our careers in oncology on what is going on and why is this real. And I think we'd done some work parallelly to highlight how these major cancer centers were charging obscene amounts for parking, which for an individual visit may seem very small, but of course, cumulatively can be large amounts. And also the fact of the nickel-and-diming that comes in for these very, very vulnerable patients and care partners.

And my interests in these transportation and parking costs and barriers have evolved since our research group has been working on time toxicity. So, over the last couple of years, this concept of the time burdens of cancer care has evolved. And initially, we were largely focusing on the amount of time spent in medical appointments. So, you go up, and it takes so long. And in qualitative interviews, patients brought up that even for simple blood draws, "I'm actually spending three, four hours out of the home." So, we actually looked at this formally because our oncology discipline didn't believe this data. They kept thinking a blood draw is 10 minutes tops; you just ask a patient to come in.

At our cancer center, patients get a radio frequency ID badge when they enter the clinic. This is to track them within the cancer center. So, using that radio frequency ID badge data and the average driving time through their home zip code, we found that actually, even a simple blood draw was taking people more than 3 hours, home to home. And I actually made a couple of residents walk from the parking garage to the entrance of the cancer center and found that it was a median of 7 minutes one way. Now, remember, these are mostly young adults in their 20s, not walking in the Minnesota snow. So, you can imagine someone who's an older adult, at risk of slipping, walking much slower. So, all of this to say, these are major, major issues that patients and care partners face, and I was very excited to read Shakira's work on this topic.

Dr. Fumiko Chino: I love how you walked us through the granular of the patient interaction that then drove you to research this type of study because, initially, you were trying to be very patient-centered in your approach, which is, "Let me separate the lab from the visit so we can save you some time." But what they told you was that, "Hey, it actually costs me more money, and it may not actually save me any time." And I think that dovetails really nicely into thinking about the study at hand, the most recent study. And Shakira, your study on transportation barriers really just came out, and it highlights the voice of the patients and the caregivers on the lived experience of cancer treatment. And one patient from your study specifically said that their travel to receive cancer care was not only wear and tear on the cars but wear and tear on the body as well. So that echoes what Arjun just said. And I think that quote really nicely highlights that it's the costs, it's the time, it's the stamina required to navigate the hospital. These all contribute to the burdens that our patients and their families carry.

Do you mind, Shakira, giving me a brief overview about why you did this work and what you found?

Dr. Shakira Grant: Sure. So, I would say to dovetail on a lot of what Arjun said, this came also what I was seeing firsthand in the clinical practice. And at the time when I was directly involved in patient care, my population was caring for older adults, primarily with multiple myeloma. My background is as a geriatric oncologist, and so by and large, that meant that most of my patients are over the age of 65. But apart from age, they're also battling other things such as disability and other chronic conditions that impact their functional ability.

And so, I kept hearing stories over and over, not only from patients, but I recognized there was an integral part that is often overlooked in clinical care, and that is the voice and the role that caregivers play, especially when we're dealing with older adults who may not have the independence to drive a car themselves to get to the cancer center because it might be disability, it might be other chronic conditions that impair their ability to operate a vehicle. And they kept talking about the same issues around accessibility of the parking structures, the time it takes for them to drive from their homes, especially when they're having their chemotherapies or other cancer therapies, and that may impact them by not feeling physically well and then needing to still get to the cancer center to see a physician or to receive additional treatment.

And then on top of that, similarly, I heard the concerns about parking because parking was not free at the cancer center for patients. And so, this is an hourly rate, and the longer you're there, you pay more money. And for many of these older adults, they're already on a fixed income, and so it becomes very difficult for them. Even though for someone who's working and has a nice buffer of income, they may be able to readily afford $12 or $15 to pay to park every time you come to the cancer center. But if you're on a fixed income, that becomes more difficult. And so that was one of the real driving reasons behind why I wanted to do this type of research in this particular area.

Dr. Fumiko Chino: This work from your team is really an excellent example of patient-centered research and explicitly examining and prioritizing the voice of the patient and the caregiver, their experiences as an avenue to help clinicians and researchers and policymakers understand where care gaps exist and how we can be doing better. And I'd love to hear from each of you why you specifically feel like this type of research is important - I know you've already mentioned some of it - and the range of patient-centered research that you have done in the past or you hope to do in the future. What is the unique knowledge that this research allows us to gain beyond some of the standard research paradigms?

Dr. Shakira Grant: I think patient-centered research is really critical, not just in helping us to set the stage as clinicians, as researchers, but it becomes important for policymakers because oftentimes, we hear the stories, and the stories are the things that are most powerful. They speak to the emotional need of people, and that in itself can be very powerful, especially when you're trying to interact with policymakers about why this particular issue is important. It is easier to do that when you have a story, when you can put a face to what is actually happening. So, it doesn't seem as abstract if we're just talking about quantitative data where we're analyzing and putting out a lot of statistics. We're talking about this patient, their caregiver, their lived experience. These are the real barriers.

So, I really appreciate doing patient-centered research because it centers the voices, the lived experiences, and that just enriches the experience, and it also gives that emotional and psychological appeal that is sometimes necessary to get the attention of policymakers and other legislators.

Dr. Arjun Gupta: Absolutely. And to follow up on that, I think Shakira's point about telling stories is very important, especially these days. We've seen so much misinformation. And I think for me personally, as a researcher, learning how to do mixed-methods work, especially qualitative work, to be able to integrate stories into all of these quantitative data elements that we have is extremely important.

To that point, I will say that when starting to research parking costs, the most impactful blog that I read on this topic was about parents whose newborns were in the neonatal ICU or the NICU. And it was such a beautifully written blog, asking someone to imagine their biological child in the neonatal ICU. And if the child had two parents, then each of the parents trying to balance work and coming to the NICU and having to pay parking fees twice a day. And to have to do that day after day and week after week and month after month, I think it's very important to share that part of the story and the horror along with that element of, "Okay, it cost $10 each time."

And so, when I think about patient-centered research and how I best integrate my skills and interest, I think about symptom intervention trials. So, how do we make people feel physically better through things like medical cannabis and access through that? And the other big thing is exploring and intervening on the financial toxicity of care, the time toxicity of care, and the logistic toxicity of care.

So, Fumiko, you've been such a champion for financial toxicity over the years. And just to go back in history a little bit, before Dr. Zafar coined the term "financial toxicity" 10-15 years ago, being bankrupt from cancer care was just something that happened. It sucks, it happens. But since then, it's been named, it's been shamed, and it's been intervened upon. And that's my hope with the time toxicity field now over the last two, three years.

And the latest thing that our group has sort of worked on while studying time toxicity is that it's not just the time outside the home, but it's also all the paperwork and administrative burden that goes along with it. And so, our team is currently trying to provide patients with proactive legal support to actually help with medical debt, insurance denials, things like that.

Dr. Fumiko Chino: I like that full scope of the patient experience when thinking about cancer care. And one thing that struck me when I thought about these studies about parking costs is that when we see someone in our clinic, you know, when we open the door and we say, "Hello," they've already had to deal with all of these transportation barriers. They've had to navigate the parking deck and walk over. And so, when we're seeing them, they've already had some amount of small trauma, sometimes large trauma, related to just trying to get in the door. And I think that really nicely encapsulates the fact that there is a larger picture that our patients are experiencing that is not just me talking to my patient and outlining a treatment plan.

And one thing I think I heard kind of from both of you is that with these patient stories, you actually get ideas for research that you may not have actually thought of on your own. Again, your patient saying that they couldn't afford Christmas presents is such a compelling anchor for why what we do matters. And when we think about trying to explore things like quality of life or frailty, or the fact that, for example, the cost of a walker may actually be outside of someone's ability to pay, and they can't even afford their durable medical equipment. These are all part of the larger care experience for a lot of our patients.

Now, one aspect about this most recent JCO OP study that I particularly loved was the inclusion of the caregiver as an essential member of the healthcare team. Selfishly, perhaps, as a prior cancer caregiver myself, now a cancer widow, I find the caregiver voice to be really underappreciated and understudied. Shakira, do you mind sharing why you felt like this was really important to include caregivers on this study?

Dr. Shakira Grant: Sure. So, it came exactly out of the reason that you mentioned. Oftentimes when we think about research, especially within the cancer space, a lot of it is centered on the patient experience. And what I've learned through clinical practice and even working in the health policy space is that cancer is a disease that not only impacts the patient but it impacts the family around them, and that bleeds into financial issues and whether or not someone experiences financial toxicity. Now, especially in the health policy world, we hear a lot about medical debt and thinking about how that then gets passed on to other family members. So, it was critical for me and our team to really think about the caregiver because we saw them as being a central part of the cancer journey or experience. We wanted to capture their voices because so often their voices, their experiences are not taken into consideration.

And I think when it's coming to think about something like transportation in particular, it's key to remember that transportation is a core determinant of whether or not people are going to be able to access healthcare. And when you are older and you have disability and you're not able to operate a vehicle, that's one aspect of it. But then there's the financial piece of the transportation, which is paying for costs to uptake your vehicle, insurance costs, parking costs, and then the other costs that happen once you actually reach the cancer center. So, it was important for us to not only understand this from the patient perspective, but we do recognize, especially with older adult caregivers, they too are taking time off from work. That means lost wages potentially for them in order to drive their caregiver to the care recipient to the cancer center. And that can have a downstream impact on them. So, it's important to amplify their voices whenever we are talking about this type of patient-centered, or should I say, patient and caregiver or patient-care partner focused research.

Dr. Fumiko Chino: Now, Arjun, I saw that you recently published a piece in JAMA Network Open on time toxicity that similarly had qualitative interviews of patients, caregivers, and actually also clinicians. Can you also speak to the importance of including caregivers in research?

Dr. Arjun Gupta: Absolutely. Before that, just I want to acknowledge that my own clinical care has evolved over time. I think I was much more immature earlier. But in my earlier years of clinical practice, it was largely patient-focused. And over time, I saw firsthand the importance of having an engaged care partner if I wanted the patient to do well. So, if our primary allegiance is to the patient, I initially used to look at it as, "I need the care partner to be on my side so that if we say the neutrophil count is 0.1 and we need to come to the emergency department, we need the care partner to be able to drive the patient."

But over time, as I matured, the care partner became a distinct human being for me. And someone put it very beautifully that the care partner's suffering, unfortunately, often lives on even after the patient's death. And in my clinical space, which is often advanced GI cancers, that's not uncommon when the median survival for the patient may be one year or so on average. And so that's where this was motivated from. And when looking at time burdens faced by patients and their loved ones, a couple of themes came up prominently. Patients often brought up themselves that, "You know, my time is precious and so much of it is used up, but it's really my loved one who's suffering." They referred to their loved one's time loss as collateral damage. They often described it as, "I am the ball that's not allowed to drop." So, my care partner is juggling four different balls, and I'm the only one that's not allowed to drop. So, all of my care partner's balls are dropping.

And one more point I'd like to raise is we often think about a care partner in the singular. So, there's an index or a main care partner. But one of the other interesting things was how often the entire network of friends and family around that patient and the index care partner were affected, which was likened to this domino effect or a rippling effect.

And so, for all of our work, I think if we're talking about the patient, I think it's absolutely unfair and not applicable if we don't consider the care partner alongside patients.

Dr. Fumiko Chino: I love what each of you have highlighted: that this is an evolving paradigm of broadening the scope of what we need to focus on. And it kind of shocks me that this is a new concept, that suddenly, "Oh my gosh, the caregiver and the caregiver team actually matter." It's sort of like how we thought of quality of life as, "Oh my gosh, suddenly quality of life matters." It used to be just, "Oh, well, you're alive, so good luck with that," or "Survivorship matters." And so again, part of evolving research to be better is to really think about the full picture for our patients, and that includes quality of life and care teams and survivorship and end-of-life care.

Now, switching gears a little bit, Shakira, I know you're coming directly off of time within the federal government, working on health policy in the House Ways and Means Committee. Can you briefly speak to your experiences in DC and your work trying to bring some of these issues to the eyes and ears of legislators and how to prioritize national solutions to the affordability healthcare crisis?

Dr. Shakira Grant: Sure. So, in DC, my work on Ways and Means under our jurisdiction largely focused on Medicare. And with Medicare being one of the largest federal insurers, with just over 66 million, I believe, as of 2024, enrolled in Medicare plans, it really brought to light a lot of the complexities at play when it comes to thinking about the issues that the older adult population and those who qualify for Medicare based on disability status could face. And so that ran the range from thinking about health equity in everything that we did, which broadly encompasses thinking about social determinants of health such as transportation, as we're discussing, to making drugs more affordable for our older adults, as well as thinking about how do we safely bring innovative technologies and new therapies to the older adult population or Medicare beneficiary space, while ensuring that we are able to be focused on containing costs as much as possible - so, thinking about financial payment models and reimbursement.

When it comes to raising these issues, I would say from my experience in DC, I believe that regardless of which side of the aisle you sit, the health of the American people is always at the forefront of everyone, of every legislator. There's always ways to think about how do we improve the health of our communities, of the people that they are elected to serve. The way to do that, however, may look different depending on which side of the aisle you sit on. But I would say efforts that could be done that will help in this space are through the advocacy, especially through the work that ASCO continues to do, especially as it relates to drug pricing and addressing the drug shortages, raising issues such as affordability, healthcare access. Those voices together are really powerful and appeal to the broader legislative landscape to understand why this is so important, especially for your patient populations.

The other aspect of this is also related to just thinking about future changes as it relates to the current political climate and a lot of the federal actions that have been taken. I think overall, there still needs to be a push to make healthcare a lot more affordable. In addition to addressing the affordability issues of healthcare, there's also the access issues and ensuring that the 21 million people who have sought health insurance through the marketplace, that they continue to be protected and that they can still continue to have access to health insurance.

And then more recently, we've seen a lot of discussion around what is happening with Medicaid, and it would be remiss of me not to mention this because of the proposed $880 billion (with a B) in cuts that is proposed to this program. And so Medicaid is a key pillar. It provides insurance for those who are oftentimes the most vulnerable. It is one of the federal programs that actually addresses social determinants of health such as transportation by actually providing and covering transportation for its beneficiaries, as well as addressing other things such as food insecurity, housing insecurity. And so it's really critical when you think about framing social determinants of health, framing access to care, to think about Medicaid especially and proposed cuts and what that would mean for the most vulnerable among us in terms of being able to access the care that they need, in addition to the other programs that I mentioned.

Dr. Fumiko Chino: Now, Arjun, I know with some concerns about federal cuts to Medicare, Medicaid, there's been some idea that maybe there's a shift of focus towards state, institutional, other organizational commitments to try to fill the gap that maybe federal dollars are departing from. Do you have any thoughts about what we should be doing within our clinics, within our institutions, within our societies?

Dr. Arjun Gupta: Yes, I think just speaking at an individual clinician or health system level, especially as it pertains to transportation and parking specifically. So, what can I or we do in clinic tomorrow? We've actually been doing some qualitative interviews on this, on how to make people's life easier. And some of the things that patients and care partners have said are actually very, very simple. One of the first things is, "I wish my oncology care team was honest with me. We know you're well-intentioned. I know you're working in a broken system. But I was told, 'Oh, it's a quick infusion,' and then I was set up for a three-hour infusion, and then it ended up taking five hours. And I understand that you're all working hard, but just tell us if it's going to be five hours. And I can then plan my day and arrange childcare and things like that." And so, I just think being honest and vulnerable with our patients is super duper important.

The other thing is things like, "Do we really need to make the patient, plus minus their care partner, come in on a given day?" So, trying to coordinate care better. And one of the more specific solutions for that is people have suggested having a designated care coordinator or scheduler with them, a one-stop shop for scheduling, which cuts down so much of this time that's spent scheduling but also avoiding extra visits. So, while these longer-term policy issues are implemented and leveraged, I think there's things we can do every day. Is that CT scan, does it need to be done, or can it be on the same day? These can make massive, massive differences for our patients.

Dr. Fumiko Chino: Shakira, any last thoughts as we wrap up this podcast?

Dr. Shakira Grant: I just wanted to add to that because one of the key things I would sum up our study in showing is that, again, transportation is a core determinant of whether people are able to access healthcare. And we found, especially that older patients, those with disabilities, low income, and living in remote areas, these are the people who are facing the most significant challenges when it comes to accessing care because of transportation. And so, when you think about interventions, an approach could be, rather than thinking about population-level approaches that incorporate everyone, rather, it may be thinking about who are the high-risk groups amongst the people that are seen within your respective healthcare system, and then targeting interventions at the individual level as well as the healthcare system level, and then building up to thinking about community-level interventions such as rideshares, investing and appealing to policymakers.

But I would say we often think about policy changes as needed to really make a difference, but it really starts at the individual level, and you can then use that to build up to the policy because in order to develop a really great policy, it takes several years, sometimes up to a decade or more. And in the meantime, what we can be doing as clinicians, researchers, consultants, are focusing on the people within our immediate ecosystem and seeing how we can build strategic partnerships to address the issues that they're facing at those individual, interpersonal, healthcare system levels, and then leveraging that to build up robust policies.

Dr. Fumiko Chino: I love it. It's this idea of not losing the forest for the trees, but also taking the time and care for each individual patient in front of us. And it's a dual goal.

Arjun, any last thoughts from you?

Dr. Arjun Gupta: Just, I read a very interesting quote which I love. Someone said - I haven't found who said this, but they're clearly very smart - they said that, “With all of this AI and stuff, the biggest technological advance will still be more time with the patient.” And I think in some of our work on time toxicity, clinicians, which is all sorts of people in healthcare, have persistently said, "I just wish I had more time." And so, I think as we think of frontline solutions, I think we need to respect our own time to be able to respect patients' and care partners' time.

Dr. Fumiko Chino: Well, thank you both for this wonderful conversation today. Many thanks to Dr. Arjun Gupta and Dr. Shakira Grant, as well as our listeners for your time today. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put Into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put Into Practice's next episode, and until then, I encourage you to continue advocating for your patients, from parking vouchers to health policy solutions.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Conflicts of Interest

Fumiko Chino

Consulting or Advisory Role

Company: Institute for Value Based Medicine

Research Funding

Company: Merck

Shakira Grant

No relationships to disclose 

Arjun Gupta

Employment

Company: Genentech/Roche

Recipient: An Immediate Family Member

Dr. Chino talks with Dr. Erin Roesch and patient advocate Julia Maues about pregnancy associated cancer with a focus on breast cancer, the most common cancer diagnosed during pregnancy. This discussion is based off an JCO OP review article published in late 2024 called “Multidisciplinary Management of Pregnancy-Associated Breast Cancer.”

Dr. Fumiko Chino:Hello and welcome to Put Into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an assistant professor in radiation oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

The incidence of early-onset cancer—new cancers in adults under the age of 50—is rising by 1% to 2% annually. Young women appear to be at particular risk, with cancer incident rates over 80% higher than similarly aged male counterparts. Collectively, that means that more patients are being diagnosed with cancer during their childbearing years. Pregnancy-associated cancer occurs in 1 in every 1,000 to 3,000 pregnancies and refers to cancer that is diagnosed either during pregnancy or within 1 year of delivery.

On today's episode, we'll be talking about pregnancy-associated cancer, with a focus on breast cancer, as it is the most common cancer diagnosed during pregnancy. This discussion will be based off of a JCO OP article published in late 2024 called “Multidisciplinary Management of Pregnancy-Associated Breast Cancer.”

I'm excited to welcome both the first author of this review article and a patient advocate to the podcast today. They are both passionate about improving outcomes for people with breast cancer.

Dr. Erin Roesch is an assistant professor of medicine at Cleveland Clinic Lerner College of Medicine and a medical oncologist at the Cleveland Clinic Taussig Cancer Institute specializing in the treatment of breast cancer. She is involved in clinical trials research, and some of her specific interests include the care of young women diagnosed with breast cancer, fertility in oncology patients, and women's health and survivorship.

Julia Maues is a patient advocate working with researchers, clinicians, and other stakeholders to ensure research is patient-centered, innovative, accessible, and inclusive. She was working as an economist when she was diagnosed with breast cancer while pregnant in 2013. After delivering her son, she found out that cancer had already spread to her bones, liver, and brain. Julia co-founded GRASP (Guiding Researchers and Advocates to Scientific Partnerships), an organization that connects and fosters collaborations between researchers and patient advocates. She is also active within the Metastatic Breast Cancer Alliance and helped write the ASCO guideline for brain metastasis.

Our full disclosures are available in the transcript of this episode, and we've already all agreed to go by our first names for the podcast today.

Erin and Julia, it's really wonderful to speak to you today.

Dr. Erin Roesch:Thank you. I appreciate the opportunity to be here and discuss this really important topic.

Julia Maues:Thank you for having me. It's very important to include the patient voice on this topic, and unfortunately, I have a personal experience with this.

Dr. Fumiko Chino:Our topic today is pregnancy-associated cancer. Erin, can you give us a quick overview of the background for pregnancy and breast cancer? I know in the recent era, breast cancer rates for those under the age of 50 have been rising faster than for other cancers, up to 1.4% per year since the mid-2000s. I'd always thought that pregnancy-associated cancer was pretty rare, and so I was really shocked to read in your paper that for women younger than 35, 1 in 6 with breast cancer are diagnosed around pregnancy.

Dr. Erin Roesch:Yes. So, a cancer diagnosis during pregnancy is rare, with the incidence, as mentioned, of about 1 in 3,000 pregnancies, with pregnancy-associated breast cancer, or PABC, representing about 7% of all breast cancers diagnosed per year. Among women under the age of 45, PABC accounts for roughly about 2.5% to just over 6% of breast cancer cases. And for women less than 35 years, this rises to about 15.5%.

Studies have shown a rise in PABC in recent years, and this is anticipated to continue with the trend of delayed age at childbearing. In regards to the pathophysiology of pregnancy-associated breast cancer, various hypotheses have been proposed to kind of try and shed more light on how this occurs and the driving factors for PABC. So these include hormonal changes that occur during pregnancy and lactation, immunologic changes that can lead to the immune tolerance of tumor cells, and also breast tissue involution that occurs after delivery and breastfeeding, which can lead to a proinflammatory state.

In regards to risk factors, these include a positive family history, which is one of the strongest risk factors for breast cancer development, this includes pregnancy-associated breast cancer, pathogenic germline mutations—specifically BRCA1 or 2—and older maternal age at time of birth. We also know that breastfeeding has been shown to have a protective effect against breast cancer development.

Dr. Fumiko Chino:So what I'm hearing from you is that just given the incidence rising in younger people and also delayed pregnancy, that this is really something that we're unfortunately going to be facing more and more frequently in our clinics and something that patients unfortunately will find that they have to face as well.

Dr. Erin Roesch:Yes, yes, I think that's accurate. And just again, I think points to the importance of awareness of this particular topic.

Dr. Fumiko Chino:Now, Julia, your lived experience in this space is really invaluable. Do you mind sharing it with us?

Julia Maues:Yeah, of course. I was pregnant at 29, and I found a lump in my breast. I had an excellent OB-GYN and team, and they took it seriously. I think she wanted to watch it for a few weeks, but as soon as it didn't go away, she ordered an ultrasound, and that turned into a biopsy, and that turned into a cancer diagnosis.

I lived near a comprehensive cancer center. I had multidisciplinary care, really excellent team, and was treated with chemotherapy during the pregnancy, which was very surprising to me and hard to accept. But they did provide me with a lot of evidence that that is the best treatment for both my baby and me. And so I did four cycles of Adriamycin-Cytoxan during the pregnancy and delivered my son at 37 weeks. He was healthy and full of hair, even though I was bald. That was very important, I think, for many reasons, but it showed visually that the placenta did its job and he was protected.

After he was born, I could do scans that I couldn't do while pregnant. I had a lot of back pain and things that were thought to be pregnancy-related, or maybe they knew, and they just didn't go there because it really wouldn't have made a difference at that point, like, the treatment couldn't be any different. But I did that scan and found out that it was metastatic, and that changed the treatment that I did after the pregnancy, and instead of eventually surgery, I just stayed on systemic therapy for that long. And spoiler alert, this is 12 years later. That baby is in sixth grade and thriving. And I am very grateful for the privilege that I have to have received such excellent care and have access to the treatments that I have had, and also the luck to have had good response to treatments.

Dr. Fumiko Chino:I love how you've taken your story and the successes, but also the horror and the terror, and really used it to galvanize your life in a mission to try to improve patient care for others. So I've always really thought that was phenomenal in terms of your mission and your drive.

Julia Maues:Thank you. I'm very, very happy that it helps other people, but selfishly, it helps me to deal with my own difficult experience, and it's been a way to make something good out of this.

Dr. Fumiko Chino:I feel very aligned with you on that in terms of my own personal story as a caregiver. It's one of the reasons why I became a physician. So I feel like you and I have a common touchstone there. And I think so many people in medicine and so many patient advocates are really trying to give back into a system to try to improve it for all because of either the ways that it helped them or the ways that they thought that it could be doing better. So thank you for sharing that with us.

Now, Julia had mentioned that the staging scans were delayed until after delivery due to some appropriate safety concerns. And I certainly know that those diagnosed during pregnancy often have diagnostic delays. Erin, do you mind discussing what delays may occur in pregnancy-associated breast cancer and if there are any solutions to improve those delays?

Dr. Erin Roesch:Sure. And I'd like to echo and certainly, you know, thank Julia for sharing her story. And I think as an oncologist, we learn so much from our patients, and so it's really, really important for us to understand, to be able to appreciate everything you've gone through. So I just, I really thank you for that.

So in terms of, you know, the delays that we see—and I think, Julia, your story through this really kind of outlines much of what we see in terms of some of these delays and challenges related to the diagnosis and the workup of pregnant women with suspicion of breast cancer. So although the majority, about 80%, of breast cancers or breast masses, rather, detected during pregnancy will be benign, any palpable mass present for a couple of weeks or more in the breast or axillary region should really be clinically investigated, you know, as your doctor did. Additionally, any other breast changes—less common things such as an asymmetry, thickening of the skin, redness of the skin, nipple changes—those things should also be investigated, you know, as they raise clinical suspicion.

Pregnancy-associated breast cancer often remains undetected in pregnant women until later stages due to potentially symptoms being masked by the physiologic breast changes during pregnancy. Studies have shown that a relatively high proportion, you know, over 80%, of pregnancy-associated breast cancers are self-palpated. We know that later stage at presentation and a delay in care can lead to an inferior prognosis or affect someone's prognosis.

So I think in terms of the challenges, in terms from a diagnostic evaluation standpoint, typical imaging modalities that we use for breast cancer, we know some can have harmful effects on a growing fetus. So the evaluation should begin, as Julia mentioned, with an ultrasound. That would be the initial gold-standard diagnostic test. And then subsequently, a mammogram with abdominal shielding can and should be used to provide additional details regarding the breast mass.

In terms of systemic staging, so I think again, as Julia pointed out, the traditional evaluation for metastatic breast cancer typically includes CT scans with IV contrast of the chest, abdomen, pelvis, and a bone scan or a PET scan. However, these imaging tests should be avoided during pregnancy, particularly during the first trimester, due to the harmful exposure of radiation and IV contrast to the fetus.

In regards to some of the solutions, I think from a systemic staging standpoint, alternative imaging can be used. So when indicated or appropriate, things such as a chest x-ray with shielding, an ultrasound of the liver, an MRI of the spine without contrast could also be considered, again, in the appropriate setting. But I think, you know, Julia certainly highlights the challenges that we face from a diagnostic standpoint.

Dr. Fumiko Chino:Julia, you had said something probably that was the most important, which is that you felt the mass and that your physician actually took it seriously. And I certainly have heard from other patients that when they were pregnant and they felt something, it was sort of just ‘pooh-poohed’, for lack of a better term, as, you know, normal changes in the breast, and it wasn't followed up to the extent that it should have. Do you have anything to add in terms of delays? I know you are certainly very active in the advocacy community, so I feel like you've probably heard every good and negative story about delays to diagnosis or care.

Julia Maues:Yeah, unfortunately, we hear these stories all the time. The clogged milk duct, which may be very plausible, but needs to be investigated, right, is not always the case. And unfortunately, anecdotally, and I know you all have been part of evidence on this, women that are Black experience this at a much higher rate. And then we see younger women with doctors that just tell them that, “Women your age don't get breast cancer.”

Dr. Fumiko Chino:Which is patently false, as we know, because the rates of breast cancer in younger women are rising. So I feel like we need to be standing on top of rooftops trying to make sure we're advocating for our patients and educating our colleagues about the early-onset cancer risk.

Julia Maues:And I'll say one more thing that I think patients also have a wrong understanding of this statistic about pregnancy protecting from breast cancer after menopause. The only thing that translates is ‘pregnancy equals lower rate of breast cancer’, right? So that is not necessarily the case while you're pregnant or in the short years after the pregnancy. It is a statistic about postmenopausal breast cancer, which won't affect the pregnant person for many years.

Dr. Fumiko Chino:Julia, this review highlights the role of the multidisciplinary team for optimal management of pregnancy-associated breast cancer. And from the article, it says, "At the time of diagnosis, multidisciplinary teams should be consulted, including breast surgery, plastic reconstructive surgery, medical oncology, radiation oncology, maternal-fetal medicine, genetics, and psychosocial services." Can you speak to who was involved with your care, including what really worked well in this incredibly stressful situation or lessons learned for what could be improved? I know you said you did have the benefit of a comprehensive cancer center and a multidisciplinary team.

Julia Maues:Yes, absolutely. A team that came from many angles at this problem was very important. I did see a surgical oncologist, a radiation oncologist, a plastic surgeon, the medical oncologist, of course. And then I had two OB-GYNs, my first OB-GYN and a high-risk OB-GYN, and I did see genetic counseling. And I think after those first appointments, the surgeon and the radiation oncologist and the plastic surgeon didn't play a role. They were going to come back into my care after the pregnancy; that was the plan. But the OB-GYN, and especially the high-risk OB-GYN, was very important. And the fact that they were in touch with my medical oncology team and they were complementing each other in terms of medications and what treatment I needed, that was very important.

Dr. Fumiko Chino:Erin, do you have anything to add in terms of coordinating these large teams? I know that the medical oncologist often works as sort of the quarterback in this scenario for these teams.

Dr. Erin Roesch:Yes, and that's exactly how I typically describe myself to patients, is kind of as that quarterback. I think that Julia's description certainly highlights the importance of multidisciplinary care, and it's really crucial for pregnancy-associated breast cancer. And it's important to recognize that it's not a one-size-fits-all approach either, and that not all patients' needs might be the exact same. But that being said, it's helpful to have, you know, an algorithm that outlines the general steps, diagnosis, and management of our patients with pregnancy-associated breast cancer. And it's really important—it's an overwhelming time for patients and their families. So it's really, you know, essential to make sure that our patients have knowledge of and access to all of the resources that are available, you know, during their diagnosis, treatment, and in survivorship. I think that again, just stressing that multidisciplinary care from the beginning is really key.

Dr. Fumiko Chino:That segues nicely into the next topic, which is: I really found the figure in your article to be particularly helpful as a flowchart for decision-making in pregnancy-associated breast cancer. How do you approach shared decision-making, patient autonomy, and informed consent with your patients when faced with some of these really heartbreaking decisions?

Dr. Erin Roesch:So, you know, just as I said, it's certainly, you know, it's very individualized, but it is very helpful to have a guide that we can follow and that we can also use for educating other providers on what are modalities that are safe during pregnancy, what we have data on, where we're lacking, et cetera. So I think that when I talk with my patients in this type of situation, you know, I think open lines of communication, transparency, super important. And I think recognizing that breast cancer diagnosed during pregnancy often occurs during a time when a woman is figuring out their life plan. They could be finishing school, family planning, you know, career goals, establishing relationships, just to name a few things. So it's helpful to be aware of these things when we're counseling our patients so that we can better really appreciate, understand their goals and, as much as possible, help them achieve their goals while also effectively treating their breast cancer. So I always really, really strive to involve my patients in the decision-making regarding their care, but also advise them that I'm there to provide full support and whatever information that I can to be helpful.

Dr. Fumiko Chino:I love that thing to highlight—that cancer doesn't define someone's existence, and they were a whole human being before their cancer diagnosis, and they should be a whole human being after their cancer diagnosis. And so making sure that we are talking to a person, not to a cancer diagnosis and a treatment plan. It's an individual on the other side.

Now, Julia, I know that you said that your stage IV diagnosis came after you delivered. I'm sure that there was a shock and horror related to that. Do you have anything to add in terms of the multidisciplinary team or how it pivoted once you got that diagnosis?

Julia Maues:I completely agree with the ‘quarterback’ name to the medical oncologist. They definitely have, even today, this role in my life, and I definitely benefited from really wonderful quarterbacks in my years. But I think another very important connection there is being able to connect to other patients with a similar experience. I did - at different times, I was able to connect to people who had just had a baby after treatment during pregnancy, or who had a child that was maybe a little bit older and they were thriving, and just knowing that that was a possibility or a likely possibility for my child, even though I was making him go through these treatments while inside me.

Dr. Fumiko Chino:Now, pregnant women, human fetuses, and neonates have additional protected status under the federal government that mandates special IRB review. This means that pregnant women are often excluded from research, often without actually clear justification, even when the research really poses minimal risk. Erin, how do we improve the body of evidence to support best care for patients with pregnancy-associated breast cancer, understanding some of these concerns?

Dr. Erin Roesch:Yes, so I think it is really important to utilize the research means that we do have. So an example of this could include retrospective analyses, you know, looking at registry data. We can really gain important, valuable information this way. Additionally, learning from thought leaders in this space and experts in this field can help providers and patients better understand the data that we do have and where our gaps may exist.

I think, furthermore, various institutions have niche programs that are dedicated to education and research for young women with breast cancer and, within that umbrella, pregnancy-associated breast cancer. So it's really important, I think, to be aware of those resources as well that do exist.

Dr. Fumiko Chino:You really highlighted something important, which is that in this situation of pregnancy-associated breast cancer, it likely is best to go to a specialty center, you know, a comprehensive cancer center of some variety, or a center of excellence so that you can really rely on both the expertise of the team but also their capacity for building that multidisciplinary team that is, I think, really required to treat a patient with cancer and pregnancy well.

Now, Julia, I personally see some parallels here with exclusions for people during pregnancy and also the exclusions for metastatic breast cancer from research studies. Do you mind speaking about that? I know you've been a strong advocate about inclusion.

Julia Maues:Yes, absolutely. We see a lot of clinical trials that include metastatic breast cancer patients when it comes to the actual treatment and the new drugs. But when it comes to survivorship trials, and let's say, what is the effect of exercise on your outcome? Patients with metastatic breast cancer are often excluded. And we are surviving too, right? We need to be studied in that scenario as well. And I think we're fortunately seeing some change in that. And there are a few trials, for example, open right now looking at diet and exercise for specifically metastatic breast cancer.

Dr. Fumiko Chino:It's amazing to think about how you've really straddled both high-risk groups, you know, the pregnancy-associated breast cancer, metastatic breast cancer, and really dedicated your life to making inroads and positive changes for both of these communities. So I really am so grateful for you for that.

We are sort of wrapping up this podcast. I wanted to give a little bit of space at the end to have any open topics, if there's anything that we feel is under-addressed or unaddressed in this topic. I know that we could probably spend, you know, five hours talking about it.

Julia Maues:I will say one thing that is perhaps the most difficult decision. When I discovered my diagnosis, I was very happy to be pregnant, but I was faced with the question of, I now have a disease that is life-threatening. Am I going to be alive by the end of this pregnancy? And in order to be alive by the end of this pregnancy, do I need to terminate this pregnancy? I think that is a question that was the most difficult one during that moment and is one that I discussed with my team. And fortunately, in my case, it was possible to give me treatment during the pregnancy and still not harm my baby. But I think this is the first thing that we're faced with at that moment of the diagnosis.

Dr. Fumiko Chino:And I think that concern is certainly even more relevant in the climate where, depending on where you live, that may not even be an option. And even, I have definitely heard some concerns about even chemotherapy while being pregnant could be potentially something that would be at risk. Erin, do you have anything to add?

Dr. Erin Roesch:Yeah, no, I think that's a valuable point too, is that again, it's a very, very challenging, scary time at initial diagnosis. And just like Julia mentioned, many women are very happy they're pregnant. And even to Julia's point earlier about receipt of chemotherapy during pregnancy, you know, many women might not think that that's possible. We have data that has shown relative safety of certain chemotherapies during pregnancy, you know, after the first trimester. And so I think it's important that again, with the shared decision-making, that women know all of this information so they can process and come to the best decision for themselves.

So, and I think also, not that we can predict the future—I always tell my patients I wish I had a crystal ball that I could tell what was going to happen in the future for people. But I think that we've had a lot of advances in terms of breast cancer treatment, and this includes for metastatic disease. And so our patients are living longer and living better. So I think that's important to remember too. And just again, make sure that we, as much as possible, have these conversations upfront with what we know and what we don't know so our patients can feel supported through this process.

Dr. Fumiko Chino:That's a really good, positive note to end it on. So I'm so grateful for your time. Thank you for this wonderful conversation today. Thanks to Dr. Roesch and Ms. Maues, as well as our listeners, for your time today. You can find the links to the papers that we discussed in the transcript of this episode.

If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put Into Practice's next episode. Until then, please stay safe.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Conflicts of Interest:

Erin Roesch:

Honoraria

Company: Intellisphere

Consulting or Advisory Role

Company: bioTheranostics

Company: MDedge

Company: Seagen

Julia Maues:

No Relationships to Disclose

Dr. Chino talks with Dr. Atif Khan and Dr. Lola Fayanju about the shift in breast cancer management from reducing locoregional recurrence and improving breast cancer mortality to deintensification, shared decision making, and improved quality of life. This discussion will be based off a JCO OP editorial published in late 2024 called “Contextual Framework for Understanding Treatment De-Escalation in Patients With Breast Cancer.”

Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

Breast cancer treatment has made significant strides in the past century, with the five-year survival rate rising from less than 5% in the early 20th century to around 90% in the present day. In today's episode, we'll be discussing the shift in breast cancer management from reducing local-regional recurrence and improving breast cancer mortality to deintensification, shared decision-making, and improved quality of life. This discussion will be based off of a JCO OP editorial published in late 2024 called "Contextual Framework for Understanding Treatment De-escalation in Patients with Breast Cancer."

I'm excited to welcome two breast cancer experts as guests today: the first author of this editorial and radiation oncologist, as well as a health services researcher and breast surgeon. They're both engaged in research to improve outcomes for breast cancer, including treatment optimization.

Dr. Atif Khan, MD, MS, is a full attending breast cancer disease site leader and Service Chief in the Department of Radiation Oncology at Memorial Sloan Kettering Cancer Center. He is also on the steering committee of the Clinical Research Innovation Consortium, as well as on the Research Council at MSK. Dr. Khan is the chair of the breast section of oral examiners for the American Board of Radiology and is active in NRG, helping develop and lead key clinical trials to optimize radiation delivery for breast cancer. Dr. Khan is also a translational science investigator of novel radiosensitizers.

Dr. Oluwadamilola "Lola" Fayanju, MD, MA, MPHS, is the Helen O. Dickens Presidential Associate Professor and Chief of the Division of Breast Surgery at the Perelman School of Medicine at the University of Pennsylvania. She is also Surgical Director of the Rena Rowan Breast Center at the Abramson Cancer Center, Program Director for Implementation Innovation at the Penn Center for Cancer Care Innovation, and a Senior Fellow at the Leonard Davis Institute of Health Economics at Penn.

Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today.

Atif and Lola, it's wonderful to speak to you today.

Dr. Atif Khan: It's a pleasure to be here. Thank you for inviting me, Fumiko.

Dr. Lola Fayanju: Yeah, thanks for having me.

Dr. Fumiko Chino: The topic today is treatment de-escalation for breast cancer, loosely based on the editorial that Atif wrote in JCO OP outlining a conceptual framework, which is primarily focused on local-regional therapies, i.e., radiation and surgery for breast cancer. The concept of rightsizing treatment has really been developing over the past three decades, spearheaded by surgical de-escalation. Lola, do you mind giving me a brief overview of surgical de-escalation as you have seen it throughout history and as currently realized in your practice?

Dr. Lola Fayanju: Happy to. So, you know, it's one of those things where I think increasingly we recognize that breast cancer is a heterogeneous condition that shares an anatomical space. And with that refined understanding of treating breast cancer, we're no longer using a very blunt and large hammer to deal with what is actually a constellation of nails. So originally, when people used to treat breast cancer, the idea was that you wanted to take as much tissue as possible. And this originated the Halstedian mastectomy, which was a radical mastectomy that often involved removal of not only all the breast and axillary tissue but also the pectoralis muscle, even some accessory nerves, that really left people with incredibly deformed body habitus as well as compromised function. And in part, that was not an unreasonable approach given that disease was often presenting in a locally advanced fashion.

However, as we have been increasingly able to detect disease at an asymptomatic, pre-palpable state, but also as our ability to treat disease at a systemic fashion has become more effective, we've been able to move from the Halstedian mastectomy to then the modified radical mastectomy, and then ultimately to even less axillary surgery, as well as less breast surgery, such that there was the advent of the lumpectomy pioneered by Bernie Fisher in the 1980s, as well as sentinel lymph node biopsy pioneered by Armando Giuliano and Don Morton in the 1990s and early 2000s. And what this allowed us to do, again, is to achieve similar if not better outcomes, because we were again catching disease at an earlier state thanks to screening mammography, but also able to provide more personalized, less morbid care that focused on just the cancer at hand with the additional adjuvant therapy of radiation to provide comparable survival to mastectomy.

What this has allowed us to do is also think about the order in which we do treatment, that is allowing people to potentially get systemic therapy first in order to convert from a more morbid procedure to a smaller, less morbid procedure. So, we've made a huge number of strides both with regards to surgery in the breast as well as surgery in the axilla, and that's been facilitated by a combination of knowing more about disease, being able to be more systemic and holistic in its treatment, and also recognizing that more is not always more. The last thing I will say is that we've also been aided not only by the adjunct radiation and systemic therapies, but also by the ability of our radiologists to localize pre-existing cancer such that we can target the area and just the area of concern, whether it's through targeted axillary dissection or through sampling a previously positive area of the breast, such that we can again be more selective in terms of the surgery people get after systemic therapy.

Dr. Fumiko Chino: Thanks for that great overview, and I really love it how you have highlighted that it's all of these advances that allow us to customize the treatment to the individual. So it's not one size fits all with cancer care. We're really trying to make a customized plan and really rallying all of the modern technologies to make sure that we're rightsizing the treatments for the individual. And I think that provides a lot of benefits for patients.

Atif, can you highlight some of the key steps to de-escalate radiation for breast cancer?

Dr. Atif Khan: I think thematically, we're seeing a very similar sort of trend in radiotherapy. Just as a reminder, radiotherapy is a critical component of breast conservation therapy and also in the post-mastectomy context for high-risk patients. Radiation has been shown to sterilize or reduce the risk of microscopic residual, reduce the risk of local-regional recurrence, and in high-risk contexts, you know, by extension, reduce the risk of all recurrences and even improve survival, for example, in the seminal post-mastectomy radiation therapy trials.

Now, we existed in a time when there was perhaps only one right way to do radiation therapy, and that's not the case now. We have many different ways that we can deliver radiation therapy. And that's important because our, as Lola said earlier, our understanding of different risk strata of breast cancer has also improved, meaning we can stratify breast cancer patients into low risk, intermediate risk, high risk, maybe even very low risk. And therefore, we can tailor the intensification of our local-regional treatments to match the background risk that may exist for that particular patient.

Now, if we consider five weeks of whole breast radiation or five weeks of post-mastectomy radiation to sort of be our historic norm, we now know that we don't have to protract the course of radiation out like that. We can treat that same target volume, for example, the whole breast, with a shorter course of radiation that generally is given over three weeks. Now, I do want to pause here for one second just to clarify for everyone listening: taking five weeks of whole breast and doing that over three weeks is not necessarily a de-escalation per se, because really the same biologically effective dose is being given. It's just being given faster. So it's not really a treatment deintensification or de-escalation per se. Now, it is less disruptive to patients, it might be less, say, financially toxic, for example, in terms of like missed days of work, etc., but it's not a de-escalation with respect to the intensity of the treatment. It's just the same treatment being given shorter, but we know that it's safe to do that.

In contrast, partial breast radiation is, in fact, a de-escalation because now our target volume is no longer the entire breast, rather, we're just treating a part of the breast, that part of the breast where the risk primarily is, which is in the index quadrant where that original breast cancer was. And at the, let's say, at the low end of the risk spectrum, we now have very good evidence, you know, 14,000 randomized women, demonstrating that, in fact, partial breast radiation in those contexts is just as good as whole breast radiation. And I always sort of half-joke that whenever this treatment is possible, we should use it because for a fibroblast sitting in the breast somewhere minding its own business, a day without radiation is a good day, right? So if we can spare that treatment to uninvolved normal cells, we should try to do that.

And then, of course, the ultimate de-escalation is to identify patients who don't need radiation at all and just omitting radiotherapy. And really across the risk spectrum, whether it's in breast conservation or whether it's in PMRT/regional nodal radiation, we are seeing the emergence of these different types of treatments, meaning kind of like the high-risk treatment, the intermediate-risk treatment, and then at the very low end of the risk spectrum, no treatment at all. But that's sort of the practice that we're living in now, and I think it's a good one. We're making progress.

Dr. Fumiko Chino: I appreciate that. The whole idea is if we can potentially omit treatment to certain areas of the body or if we can omit it completely, we're certainly doing a favor for our patients if it's not going to increase their overall risk. We had talked, I think between the two of you, about some of the benefits of potentially omitting or reducing morbidities from, for example, surgeries or comprehensive treatments. Atif, do you want to take it first? What are the actual de-escalation risks? What are we potentially putting at risk when we talk about de-escalation or deintensification?

Dr. Atif Khan: Yeah, great question. I mean, I think the primary risk, which is, you know, a scary thought, is that we de-escalate or we do it too quickly or we find that, in fact, reducing the intensity of treatment leads to an increase in the recurrence risk of breast cancer. That's a very scary thought. I will say that this process of creating options, you know, treatment options, de-escalated treatment options, has been quite successful. For example, I'll open it up to Lola and you, Fumiko, but I can't really think of a clear example in which the de-escalation trial went in the wrong direction. Like, they've all sort of gone in the same direction, which is that the de-escalation or deintensification studies have generally been successful, meaning that we were able to preserve the excellent oncologic outcomes that we are used to seeing with less treatment. That's a testament to kind of how careful, you know, the scientific process is with respect to these practice-defining trials. They go through multiple levels of scientific review. It's a multidisciplinary group of individuals that's looking at this. And I would say the endeavor overall has been quite successful.

Dr. Fumiko Chino: Lola, anything to add?

Dr. Lola Fayanju: Yeah, I think when we're thinking about the risk of de-escalation, I would put them into three categories of risk. So, there are risks to the individual, that is, you know, we're actually de-escalating in the wrong person because we have an insufficient amount of information about whether they meet the criteria for de-escalation.

There's, I think, risk to the population in terms of are there groups of people who are systematically not benefiting from the de-escalation or who should not be benefiting from de-escalation because again of an underappreciation of how disease might work in that group or because the practice patterns where those people are getting care will not be amenable to de-escalation ultimately being of a good thing for them because they're not getting the other components of care that frankly are needed for de-escalation of one modality.

And then three, I think there's a risk to our collective knowledge about cancer because when we're not collecting information about what happens after six weeks of radiation or how many lymph nodes are positive, we just know a little bit less about the natural history of the disease and the natural sequelae of treatment. Again, that knowledge may be worth forgoing given the morbidity to patients and the non-benefit with regards to recurrence and survival, but it's real. It means that our retrospective reviews look different. It means our ability to have preliminary data for other types of things look different. With regards to the populations, it means that whenever we're thinking about de-escalation, we need to think hard about how to translate what we see on the podium at San Antonio or ASCO into clinical practice. And that requires, I think, more care than is often administered.

Dr. Fumiko Chino: Yeah, I'll quote directly from the manuscript of the editorial that we are basing this podcast on, and it said basically, "American women ascribe a high utility to remaining without evidence of disease." And that really sticks with me in that, even though there may not be a survival benefit, an increased risk of recurrence is not without a personal, financial, and physical burden on patients, even if that difference is small, it may be meaningful for the person in front of you.

Now I'll also shift focus slightly and just mention that we're primarily talking about local therapy here, but I'd be remiss to not highlight that there are gains in de-escalation for systemic therapies from, for example, RxPONDER, allowing us to safely omit adjuvant chemotherapy for many node-positive patients; B21, showing that monotherapy with radiation may be actually even better than tamoxifen monotherapy with no metastatic or survival differences; and of course, the PERSEPHONE trial that demonstrated that six months of trastuzumab was non-inferior to 12 months, although, granted, there were many caveats leading to poor adoption of this in practice.

Now, Lola, I know you've already mentioned this, but there are maybe some concerns that you see about broad adoption of these practices into, for example, surgical de-escalation. Based on what I know is stark disparities in clinical trial enrollment in certain populations or in maybe even clinical trial protocol adherence, are there any specific populations that you want to highlight that might be hesitant to apply this clinical trial podium data to?

Dr. Lola Fayanju: That's a great question. So, as an example, when we think about the SOUND trial, which was recently published and demonstrated that in women with early-stage breast cancer who were undergoing breast-conserving therapy and had normal axillary evaluation prior to surgery, that sentinel lymph node biopsy could be safely omitted without detriment with regards to long-term outcomes, you need to think about the context in which that preoperative ultrasound is being done. So, at different institutions, whether or not an ultrasound is routinely done, whether or not that ultrasound is done prior to biopsy, all of these things have implications for how likely you are to have a false positive after biopsy (so it's preoperative, but it's post-biopsy) and also what you're going to do about it, whether you're going to act on it, whether you're going to go ahead and proceed with sampling that node if it looks enlarged, putting something in it that means you retrieve it. If it demonstrates a small amount of cancer, potentially consigning someone to either an axillary dissection or preoperative systemic therapy that they might have forgone had you had the full picture of surgical pathology.

So that's just one example of how the context in which implementation occurs is really important because you have to take into account local practice patterns and what that means with regards to how we interpret the data that was used in the trial to then implement this practice in real life.

With regards to populations that need to be considered, I think in terms of centering equity, both domestically but also at a global level, thinking about, for instance, how we stage the axilla, how we map the axilla. What's the facility for lymphoscintigraphy as well as for localization of a previously positive node? So, there are many countries, many quite wealthy countries, in which use of radiocolloid is not routine, where it is primarily that people are using some type of tracer blue dye, for example, and therefore would not strictly be meeting the criteria for optimal sentinel lymph node mapping that would allow for a low false negative rate after neoadjuvant systemic therapy.

In the United States, we might be in places where you have patients who are having surgery with people who don't do that much breast surgery and who are less likely to have a successful and correct yield of lymph nodes at time of sentinel node biopsy. And so, you know, these are people for whom there might be actually clinically significant disease that's being left behind if not being done by someone who has a lot of experience working with dual tracer as an opportunity to localize a preoperatively positive lymph node. So again, thinking about both the availability of materials as well as the expertise of the local practitioners means that people in less or differently resourced settings may not benefit from implementation in a way that actually leads to appropriate outcomes.

Dr. Fumiko Chino: Yeah, I love it how you highlight that there's global differences, but there's also just in the US differences in capacity and skills within doing these, some of these presurgical and surgical evaluations. All three of us work at world-leading cancer centers, and I recently just transitioned from two top cancer centers in the United States, but I was actually kind of shocked about the differences even between the two major centers about how we do ultrasounds, for example.

Now, Atif, I've noticed that some providers don't really feel comfortable combining the information from various de-escalation trials in practice, i.e., so for some patients that might have had sentinel lymph node biopsy omitted per SOUND, they may be less likely to actually get PBI and instead, you know, prefer to treat whole breast radiation to cover the axilla. So, in this respect, it seems like we're kind of taking like one step forward, one step back. And are we de-escalating surgery to just escalate radiation?

Dr. Atif Khan: Fumiko, I agree with you. It'd be very counterproductive if we found that de-escalation in one domain was leading to escalation in another domain. I think the example you cite is a good one. If we are moving to a world without sentinel node biopsy and let's say clinical staging only, does that then mean that we have to, for example, give up on partial breast irradiation and treat everybody with whole breast radiation on the notion that low axilla, for example, is going to get some therapeutic effect? And I would submit for everyone's consideration that no, we in fact should not do that. We spent years developing the partial breast irradiation literature. We know that PBI has less acute toxicity. In every single trial, it has less fatigue, and it actually has less late toxicity in some studies, which is not surprising because remember, you're treating less tissue, you're treating less stuff, and that's a good thing.

Now, coming to SOUND and INSEMA, on the sentinel node arms of both of those studies, the rate of additional positive nodes is very- around, 10%, and that's pretty low. So I would submit for everyone's consideration the idea that if your patient is node-negative by SOUND criteria, let's say, right? They're very likely to be pathologically node-negative. And you can actually treat them as if they were pathologically node-negative. And that's kind of how we've adopted the findings of both SOUND and now also INSEMA from San Antonio, meaning that if a patient is eligible for PBI based on everything else, and she is node-negative by SOUND criteria, then we will offer them PBI in exactly the same way as we were before these trials were reported.

I also wanted to make one observation on your prior comment, Fumiko, if I may, about the de-escalation of systemic therapy. One thing that has been on my mind quite a bit is, particularly with, let's say in the elderly group where we have been struggling with kind of like the best monotherapy, right? Should it be five years of endocrine therapy? Should it be a short course of radiation, or do patients really need both of these treatments? And this is topical because the EUROPA trial, one of the endpoints was reported at San Antonio, the quality of life endpoint. Not surprisingly, a short course of radiotherapy was sort of associated with better quality of life than the endocrine therapy.

But I think we may be missing one potential opportunity in this sort of idea of like, we have to either do the radiation or the endocrine therapy, which is we might be able to give a little bit of systemic therapy and a little bit of radiation therapy. This line of investigation or line of thinking doesn't really exist right now. Like that conversation is interesting. So for example, can we give, for number one, can we go from AI back to TAM, right? Because AIs are just, there's just, the quality of life is worse. And can we give a lower dose of the TAM, monitor for compliance, and then give a little bit of radiation, you know, let's say PBI or something? And maybe that's the way to do that. And you could take that idea and you could apply it across different contexts even in breast cancer. And I'll note that that is how kind of the Hodgkin's lymphoma treatment evolved over time. At the low end of the risk spectrum, they kind of said, “Okay, a little bit of chemo and a little bit of radiation is better than just giving a lot of chemo or certainly a lot of radiation.” And you know, that worked. And I think at the low end of the breast cancer risk spectrum, we might start thinking about that kind of line of investigation.

Dr. Fumiko Chino: You want to ‘Goldilocks’ this situation. You want to try to find something that's just right. And I love that. And I think that sort of out-of-the-box thinking is very helpful when we think about how omission seems very clean, "you just don't get this," but deintensification, simultaneous deintensification, I think has a lot of appeal there.

Lola, do you have anything to add about that?

Dr. Lola Fayanju: I have to acknowledge the bias of three local-regional therapists on this podcast, I’m outnumbered by our two rad oncs. But just wearing my medical oncology ally hat, I think one of the challenges is also that for many of them, the ability to prescribe effective forms of systemic therapy, including CDK4/6 inhibitors, for example, is sometimes predicated on information we obtain at surgery. So, when we think about implementation, which is really, you know, an area of research for me, whether it's trying to implement the SOUND trial, again, in an institution where everyone's getting an ultrasound prior to biopsy, absolutely. But in an institution where either it's completely ad hoc, so it's kind of the ‘wild, wild west’, you have no idea from radiologist to radiologist who's doing ultrasound before or after biopsy, and also frankly, what is the kind of false negative rate at that institution, recognizing not everyone's working at the kind of places we work at. Are we doing patients a disservice?

But then, in addition, thinking about working with insurance companies, right? If we're trying to say, “Okay, we are no longer going to do sentinel node biopsies,” but that's actually required for the administration of certain medications, we put our medical oncology colleagues in a bad position in terms of their ability to actually get certain types of treatments paid for and approved. And so again, thinking about the consequences of our choices for patients, I think it really points to the fact that multidisciplinary consultation is increasingly going to be needed because we can't de-escalate everything. I think we all agree most cancers need to be treated in some fashion. But, you know, if we take away surgery, we take away radiation, we take away systemic therapy, suddenly we have a cancer that's just sitting there. And for some people, that's the right thing. Again, thinking about shared decision-making, for some patients with other morbidities and/or older age where they're unlikely to have any kind of meaningful threat from disease being left in place, well, that is the right thing potentially. But for a majority of our patients who actually want some form of treatment, I think we do need to think about the implications for our other prescribing providers, what that means, how we can help them, even as the clinical trial data suggests that there aren't major changes in adjuvant therapy or radiation prescription when you omit sentinel node biopsy, at least in the trials that have so far been shown.

Dr. Fumiko Chino: This is a nice segue to my last point, which is to talk about how these discussions of de-escalation, these decisions should really be made after the full multidisciplinary input. And yet, I feel like I've seen our specialties get increasingly disconnected in this kind of era of Zoom conferences. There seem to be less face-to-face meetings. There seems to be decreasing space for our co-shared clinics. And I just wanted to ask both of you what you think our responsibility is to each other and to our field to ensure that we're really working on these things synergistically.

Lola, you just mentioned some of your thoughts, but do you mind speaking about the multidisciplinary conversation or even how we're designing research?

Dr. Lola Fayanju: I think, with regards to the research, I'll start with that first, it means that, I think we're less going to have trials that fit in certain kind of cooperative groups that are more geared towards radiation or what have you. I think, increasingly, we should be having MPIs, you know, co-PIs who are from different modalities. I think that that's going to allow us to bring our different lenses to constructing the trial, to ultimately interpreting the result. I think we'll only grow from that. I think the era of having a bunch of medical oncologists or surgeons or radiation oncologists as the primary authors really should probably shift.

I think we need to think more globally about multidisciplinary care and what those, quote unquote, “tumor boards" should look like. And thinking beyond our own institutions, again, we're relatively privileged in terms of being at places where we all have at least weekly, if not bi-weekly multidisciplinary tumor boards. Most cancer care in the United States is happening in the community where a patient walks into, often a general surgeon's office, and that person will get surgery upfront whether they need it or not, or whether they should be getting systemic therapy or not first. And then from there, they will then be referred to a medical oncologist who may have had no input as to which procedure should have been omitted or discussed or vetted prior to meeting that person. And so, I think our greater challenge is how to bring in the global oncology community, and by global, I mean truly across the globe, across the United States, across the world. And it might be that ASCO and JCO, places like this for discussion, is an opportunity for us to connect people, connect our communities, and not having us work in silos, both at the institutions in which we currently are employed, but also at a broader level.

Dr. Fumiko Chino: Wonderful statement. Atif, anything to add to that?

Dr. Atif Khan: Yeah, I think you're pointing out an important thing, Fumiko, which is, you know, we are somewhat more fragmented since the pandemic, and we're kind of in our own spaces, and that is potentially a problem. I think in breast cancer, the different specialties are often existing in kind of a very cooperative matrix, and I think that ends up meaning that we're able to really provide high-level care to our patients. I think there are other specialties, I know, where the specialists may be existing in a somewhat more competitive matrix with each other, and I think that ends up potentially being counterproductive for patient care. So I think this is probably a thing that we need to have more conversation around and sort of thinking about how do we bring the different vantage points together in the interest of the patient and not lose that multidisciplinary care that we'd become so used to and that's provided such excellent outcomes.

I think on the research side, I don't want anyone to sort of be left with the idea that there's just one specialty that's sort of driving, you know, the design of these trials. From my own first-hand experience, both at Alliance and NRG, there's a lot of scientific review that happens, and I spent quite a bit of my energies over the past decade and a half kind of convincing medical oncologists that a certain local-regional question is warranted. And, and you know, that's part of the process. I appreciate that because they're not just experts in their field. You know, we all eat, breathe, and live breast cancer. So, you know, they have keen insight into the local-regional management as well.

Dr. Lola Fayanju: Yeah, I have to say I love the cooperative group meetings. That's kind of where the sausage gets made. And I think it is really exciting that you have people from different disciplines sitting together, proposing trials, vetting them. It feels like you're seeing the future in the present, which is really exciting. And, you know, I think what we're all striving to do.

Dr. Fumiko Chino: I love that hopeful conclusion, and I really am so grateful for both of you for this wonderful conversation today. Many thanks to both Dr. Khan, Dr. Fayanju, as well as our listeners for your time today. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put into Practice's next episode. Until then, I encourage everyone to continue doing the work that they find meaningful for their patients, for their community, and for themselves.

Dr. Atif Khan: Thank you.

Dr. Lola Fayanju: Thanks so much.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Disclosures:

Atif Khan: Stock and Other Ownership Interests: Novavax, Xtrava; Research Funding: Clovis Oncology, Merck KGaA, Varian Medical Systems; Patents, Royalties, Other Intellectual Property: Use patent for the drug riluzole awarded to Rutgers University with me as inventor.

Oluwadamilola Fayanju: Research Funding: Gilead Sciences

Dr. Chino discusses the past, present, and future of prior authorization in cancer care with Dr. Michael Anne Kyle, a health policy expert with a research focus on utilization management and patient burdens from prior auth.

TRANSCRIPT 

Dr. Fumiko Chino: Hello and welcome to Put Into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability and equity.

On today's episode we'll be discussing prior authorization in cancer care. Prior auth has been a recent focus of healthcare policy and reform, given rising demands seen by both providers and patients. I'm excited to welcome an expert on prior authorization to the podcast today. Dr. Michael Anne Kyle is an Assistant Professor in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine at UPenn. Her work focuses on defining and measuring patient administrative burden in cancer care delivery with a focus on prior authorization and how it impacts cancer care delivery, including patient wellbeing and outcomes. She holds a Ph.D. from the Harvard Business School, an MPH from the Harvard T.H. Chan School of Public Health, and a Master's in Nursing from the UPenn.

Our full disclosures are available in the transcript of this episode, and we've all already agreed to go by our first names for the podcast today.

Michael Anne, it's so great to speak with you today.

Dr. Michael Anne Kyle: It is so great to speak with you too, Fumiko. I'm really excited about this conversation and our shared interest in improving prior authorization.

Dr. Fumiko Chino: I love it that you've taken time out of your day to talk to me.

To start us off, can you tell us a little bit about yourself and your career? How did you transition from being a nurse into a health policy researcher? Did you always plan on a career in research or was there some specific event or transition that put you on this path?

Dr. Michael Anne Kyle: There was not. And so for anyone who's listening, who isn't sure what they want to do, I guess I have a good story to show that you actually don't need to know in advance. I started out as a critical care nurse and I still actually work as a critical care nurse. But as I think anyone who is a clinician who's listening to this knows, when you work in the healthcare system you just see so many things that could be different, that could be better. You notice the ways that the systems like really aren't set up for us to do our work or to take great care of our patients some of the time. And so that's really what sparked my interest in policy and in research. So I had really no background.

After working in a hospital, high acuity critical care, a lot of oncology, I spent several years working in community-based programs in New Jersey and this is before the Affordable Care Act. We were focused on access to medication, trying to get people more access to Medicaid, and did work around the initial rollout of the Affordable Care Act. And that experience where I spent a lot of time helping people enroll in social programs really gave me like some of the first insights into how much paperwork and how much time and how tedious it is to figure a lot of this out, even if you had someone helping you it’s still challenging. And that sort of stayed in the back of my mind as I went to grad school. And really what got me interested in like all the non-medical side of patient care is just like my friends and my family talking to me about it. And I think it's something we all just experience in our lives, but there just wasn't a ton of research. And so I've really been motivated to try to put some, like, numbers and evidence beside all these experiences that we know very deeply.

Dr. Fumiko Chino: So what I'm hearing is that you learned yourself by doing the work, how difficult the work was to actually obtain services for your patients, and so you decided you needed to go upstream to try to address some of the policies that were fundamentally broken, causing these horrible situations for your patients.

Dr. Michael Anne Kyle: So well said. Yes.

Dr. Fumiko Chino: Now, I heard that you just moved from Boston to Philly. How's that transition going?

Dr. Michael Anne Kyle: It's great, it's great. Many of the same familiar faces and also exciting to meet new people, learn new things, try new restaurants. So yeah, overall I feel very lucky.

Dr. Fumiko Chino: Well, with that background, we need to dive into our actual topic, which is prior authorization. It's unlikely that anyone listening to this podcast has not encountered prior authorization in their practice or due to interactions with insurance for themselves or for their family members. Can you give me a quick overview about prior authorization? What it is, what it is not, how did we get here?

Dr. Michael Anne Kyle: Oh, so every healthcare system needs some sort of coverage policy. What services are we going to cover and at what cost? And there's many ways to do this. There are countries that sort of set this up nationally. Here in the US, we do not do that. We do it prescription by prescription, and that's how we end up with prior authorization. So basically, prior authorization is a request you submit to get approval for coverage for a drug or a service that you want to give your patient. And so you may need to submit, and again, I'm sure everyone listening knows this well, but it can range for something very quick like, “Yes, this person has like the genetic target for this drug. Check, they can have it,” or it can be a more complex, protracted exchange. That is the sort of intellectual side of this. And I want to separate that from like the actual decision making from the other huge piece of prior authorization, which is how we operate it. And that is the bureaucracy and the fax machines and the time on hold, which has a separate bucket of problems. And so I just want to sort of carve out those two categories when I think about prior auth and what we need to do.

Dr. Fumiko Chino: One thing I always try to say is that even with prior authorization, even when it is working as functions, it is itself not a guarantee that a claim is even going to be approved. You can obtain prior authorization and then still face a denial for the actual claim, which is even more frustrating. And I think this kind of cumulative burden of suffering seems to me to be at an all-time peak. So can you give me a little bit of background about how the US healthcare system evolved to include prior authorization? Like why does this really even exist?

Dr. Michael Anne Kyle: Great question, and you'll get a different answer depending on who you ask. But overall, we need as a society to make a decision about the services that we are going to provide to one another. There's many different elements to that decision. One of the challenges in the United States is that we have little to no policy around cost. So when our healthcare can cost an unlimited amount, that makes it higher stakes and a trade-off is that there can be other restrictions on access. So we really don't have any constraints on cost in the U.S. other than administrative tools like prior authorization. And so that leads us to use it, I think, in ways it wasn't designed for, because there is a clinical use of prior authorization that's very appropriate, that we are doing complex things with patients that may or may not be a good fit, and we really want to figure out if this is the right match.

That is separate from healthcare is very expensive and unaffordable and we have no way to try and solve that problem except to try and put more restrictions in place, like making people go through a bunch of approvals and either discouraging them from going through that process or, you know, causing attrition through the process.

So I think one big element to how did we get here has to do with healthcare being very expensive and I think that dominates our minds. And I think there are other rationales for prior authorization that are very appropriate. But I think to your point, it's hard right now to see the times where it makes sense to go through this review process because so often you're experiencing prior authorization for treatments and medications where it just doesn't make any sense.

Dr. Fumiko Chino: One thing I've heard you speak before about is the Medicare Part D protected status that requires coverage for all or substantially all of drugs in the anti-cancer therapy treatment. Do you mind speaking a little bit about how that affects utilization management?

Dr. Michael Anne Kyle: Yes, great point. So one of like the most strictest restrictions you could put is exclusion - so you could just not cover a drug or a service. And we often don't think of that as a coverage restriction, but of course it is. But as you said, there are certain types of treatments and services where we have put in place policies to prevent exclusions because we thought these were important treatments and we didn't want them to be excluded from coverage. And in the Medicare program in Part D, which is the outpatient drug benefit, there are several categories of medications that are protected classes, and one of them is oncology drugs. So that means oncology drugs cannot be excluded from the Medicare Part D program unless there's a substitute. Like for example, if the drug goes generic, you could just cover the generic, but otherwise you have to cover everything. So that means that the only mechanism available to try and influence decision making and influence utilization is prior authorization. And that, I think, contributes to why we see such tremendously high rates of prior auth in oncology drugs in particular.

Dr. Fumiko Chino: So you're saying that a policy that was put in place in theory to help protect people with cancer may actually be placing disproportionate burden on them?

Dr. Michael Anne Kyle: Yes.

Dr. Fumiko Chino: Ironic.

Dr. Michael Anne Kyle: Yes.

Dr. Fumiko Chino: Virtually all patients and providers that I have talked to have felt like prior authorization has gotten worse in the last five years. Is this just a feeling or an emotion or does the data support that we're dealing with higher prior auth burdens more than ever before?

Dr. Michael Anne Kyle: Yes. So I think one reason prior authorization has come to the forefront of people's attention is because the prevalence is increasing. The reason for that seems largely to be driven by some larger changes in coverage, notably increase in managed care. So most of the Medicaid program is now in Medicaid managed care. In Medicare for older adults, Medicare Advantage is now a huge proportion of that program. So as managed care coverage becomes more prevalent, with that comes more utilization management tools. So then you face it more and more in your clinical practice and for your patients. So that's one major driver. And then the other thing is that as the cost of drugs goes up, so does the effort to contain costs.

Dr. Fumiko Chino: The downward pressure for cost management.

Dr. Michael Anne Kyle: Exactly.

Dr. Fumiko Chino: Now, you said managed care. And I just want to clarify for our audience, when you say manage Medicare or managed Medicaid, what do you mean?

Dr. Michael Anne Kyle: Thank you for reminding me to clarify. So in the sort of classic Medicaid or Medicare programs, or how insurance used to be when those programs first started in the 1960s, is, you know, you would like get your insurance card and you can just go around to anyone who takes that insurance. Managed care is just like a more active type of insurance where you'll have like a defined network - these are the doctors who are in your plan that you can go see, otherwise, you have to go out of network or these are the services that are covered, or these are the drugs that are covered. So managed care basically means the insurance company is taking a much more active role in the design of the benefit and so then that's why you'll see more utilization management.

Dr. Fumiko Chino: So instead of, for example, straight state Medicaid, which would be a state provided, federally funded plan, it's a private company who's actually providing those services through a contract through the state.

Dr. Michael Anne Kyle: Yeah.

Dr. Fumiko Chino: And similarly for Medicare Advantage plans, it's a private company who has decided to take the money from the federal government and then ends up providing your health care as someone who's over 65 who signed up for an MA plan.

Dr. Michael Anne Kyle: Yes. And there's two reasons that contracting ends up happening. One is that it's easier for budgeting purposes for the state, just kind of like issuing a contract. But the other thing is that states don't have the capacity to administer complex benefits. And so there aren't really like people to implement prior authorization or this type of complexity, like in the government itself. And so that's why we tend to see these kinds of practices more in insurance companies.

Dr. Fumiko Chino: Yeah, I was shocked. You know, one of the great wins of the, for example, Affordable Care Act was expansion of Medicaid, which seems great, you know, to provide health insurance to more people. But then along with that came the rise of the managed Medicaid programs, which is essentially, it sounds like states kind of got overwhelmed and could no longer manage their patients on Medicaid. Does that seem accurate?

Dr. Michael Anne Kyle: I think there's a couple of things. So one, this is the time period when I was still working in a lot of like, on the ground Medicaid public health work. So Medicaid expansion happens like still kind of in the aftermath of the Great Recession. So there had been tremendous layoffs in like, reductions in state capacity, while at the same time there was this huge expansion and like their scope of work. And so I think like a lot of the reason that managed care arose was that like they're just, you know, there had been these huge layoffs and there weren't people left in the Department of Health or in the Medicaid office. And so it was necessary to bring in external partners because the government had been understaffed.

Dr. Fumiko Chino: It's such a good point. I actually love this little bit of history you taught me because I'm always trying to tie the red thread to the red thread. Like this policy led to this either benefit or deficit. And I think, you know, stepping back one click further to say this was the environment in which these policies were enacted is so helpful when we put these things in context. It has like the benefit of talking with someone who's really a policy expert, that really helps me understand these things better.

Now, most of the data on prioritization has been really physician survey data. It shows that we hate it, it wastes our time, it increases staff allocation, it causes endless frustrations for us. Now, your work has mostly been focused on the burden on patients. Can you share what research has shown about this?

Dr. Michael Anne Kyle: I decided to focus on patients because there was just no evidence. And so there's not a ton, but there is some evidence about the experience of physicians, and everything you said is spot on. But my work finds that like you think that the pie is just what the physicians are dealing with or what the health system is dealing with, but actually like the pie is even bigger because there's this whole other chunk of work that patients are doing that we haven't really accounted for. Because of course you are spending your time after hours on hold, doing peer to peers, but at the same time, like letters are getting sent to the patient's house and they're trying to figure out what does this mean and they're also making phone calls, trying to understand what happened.

So I started this work with a national survey of adults 18 to 64 who are insured. This is just like people off the street, like not necessarily any particular health issues. And 1 in 4 people said they had delayed or foregone care in the past 12 months due to an administrative barrier. And one of those barriers was prior authorization that patients reported. And the structure of that question is the same as the way we ask questions about access barriers related to cost. And so the magnitude of barriers related to these administrative burdens is about the same as the barriers that people are reporting related to cost. And I think that's really important because we all have this sense that it's a hassle or a problem. I think it's only recently that we're understanding that it's not just frustrating, that it actually really does affect access. So that was like one step.

Then I have another piece of work building on that where I thought, okay, so patients are reporting that this is a problem and candidly that's sufficient because they're stressed and they don't feel well. But I looked at oral anti-cancer drugs and said, “Okay, like can we observe in data this phenomenon that patients are reporting that they're having issues with delayed and foregone care?” One of the challenges with claims data is you only see the claims that got billed. So we can't even see the people who got a prescription and never filled it. And I'm sure that you have many personal experiences of that with your patients and so do many of the people listening. But I'm not even able to see that in claims. So I just looked at people who were already taking a medication, already taking an oral anti-cancer medication. So we think, “Okay, they're consistently filling it so we know they're like on this regimen, and then their plan introduces a new prior auth policy on that drug and what happens to them?” And we find that people do experience delays in foregone care, that people with a new prior auth introduced on this drug they were taking have an average of a seven-day delay in their next fill after the prior auth, and that they have about seven times the odds of never filling that again. And this is for people, remember they're already taking this medication, which means they're connected to care, they have a doctor who's following them and there are policies saying in Medicare, and so this is in the Medicare population and there are Medicare policies which say, you know, you're supposed to just like roll people into coverage. If they already are on this medication and there's a prior auth, you're just supposed to continue and not impose a new prior auth on them. And that may be true, but in practice that policy isn't working because there's a delay of some kind.

We don't really know what's happening in that time. We just know there's a disruption. And whether it's because they have to do a prior auth anyway or they found out they didn't need a prior auth, the point is like there's an administrative barrier that's arising for people who are then not taking their imatinibs, not taking their erlotinibs, not taking their abiraterone. So like it's really concerning and that does not get us to health effects. One of the challenges in studying health effects is that the sample sizes get smaller and smaller and it's hard to attribute outcomes, especially for people with complex illnesses, to like one particular event or one particular cause. So that's something that sort of remains on my bucket list and hopefully on other researchers' bucket lists. But I think that you as a physician and the other people listening get a contextual sense that these are drugs that you really shouldn't be going off without, like a planned clinical reason.

Dr. Fumiko Chino: You know, the research that you just discussed was published last year in JCO, and I remember when I was talking to you about the study that you said something along the lines of you couldn't do an updated analysis now because this was a plan that didn't have a prior auth, that now needs a prior auth. And so you were looking at these transition points, whereas, by the end of the study period, basically every single plan had prior auths.

Dr. Michael Anne Kyle: Yes. So that study we looked at data from 2010 to 2020, I believe, or 2021. But most of these switches of like introducing new prior auths were happening in the first five years, usually before 2015, 2016. So I was trying to look at newer drugs like you said, but they're all coming onto the market with prior auth, and I can't study the new stuff because there's no variation to study. So thank you for mentioning that.

Dr. Fumiko Chino: So you can't document the harm of prior authorization because the best case scenario of no prior authorization doesn't exist.

Dr. Michael Anne Kyle: It's getting rarer and rarer for the oral cancer drugs, that's for sure.

Dr. Fumiko Chino: Now transitioning a little bit, there were many people, myself included, that were anticipating that prior authorization reform would make it into the lame duck session closing out 2024. Do you have any policy updates or insight into this?

Dr. Michael Anne Kyle: So I think the updated Improving Seniors’ Timely Access to Care Act, I've been following that for a couple of years and I think the latest iteration is quite good. It really focuses on these, like, administrative improvements that I think are really an urgent priority because there's no reason that we need to be having all these hassles with paperwork in 2025. I just want to mention this bill includes actual phrasing like a facsimile does not count as electronic documentation. And I was thrilled to see that.

So what I like about this bill, and I hope it will survive and endure, is that it speaks to a bunch of priorities that I think are important. One, everything needs to be automated or everything needs to be electronic. We’re still doing way too much fax, way too much paper. The bill doesn't mention whether the electronic requirement includes appeals, and it really should. If I was going to have one strong piece of feedback, it must, because I'm concerned that if we make the initial application process online, it'll just get denied and then appeals will be on paper and then we'll be back to square one. It also will really increase reporting and data access which will be helpful. One of the challenges in studying prior auth is that it's hard to get good data. Like I said, claims data, we only see things that were billed. We don't really have a great sense of payer policies. And this bill would require reporting from payers to say like what their prior authorization requirements are, denials, appeals, grievances and so on, which will be very helpful.

Although I want to highlight on this point, there's some new work on billing, which I don't think will come as a surprise to any of us that there are unfortunately inequities in the appeals process. And so this is work by Alex Hoagland and Michal Horny and colleagues and they looked at preventive services which are supposed to be covered under the Affordable Care Act. So you have some like objective sense of what the bill should look like. And they look at errors and then they look at appeals. And there are inequities by race, there are inequities by education and income in who is even appealing an erroneous bill and then how successful you are in appeal. And so while I think more transparency throughout this process is great, I remain concerned that like relying on patients and physicians to recognize and initiate appeals places disproportionate burden on our patients who can least afford it.

Dr. Fumiko Chino: I was personally very disappointed that the Improving Seniors’ Timely Access to Care Act, which is the world's longest House and Senate bill title, wasn't part of the end of year spending package. I was really hoping we could pass it through the finish line, especially because it has a zero-cost dollar from the CBO, which was a major point of resistance before. And I know this is something that both our ASCO and ASTRO, our large societies for oncologists, have really been trying to rally support around consistently and it really does seem to have bipartisan support.

So outside of federal legislation that did not make it into the spending package, how do we fix this? You know, I was rereading your New England Journal of Medicine 2023 Perspectives, highlighting some potential consequences and barriers to prior authorization reform. Can you discuss this as well as whatever specific federal, state, institutional policies or even really provider level advocacy that you feel like could get us out of this mess?

Dr. Michael Anne Kyle: Sure. I still have hope for the Timely Access to Care Act because it's been kicking around for a few years and it keeps getting worked on, improved. So hopefully 2025 will be our year. The perspective that you're talking about refers to a CMS rule that at the time was open for comment but has since been passed and is scheduled to sort of go into service in 2026, 2027. And that incorporates a lot of the same elements as the Timely Access to Care Bill. So for example, it requires that these processes be electronic. Again, the question of appeals is a little bit vague, but making them electronic, requiring the reason for denials to be provided, providing paperwork to the patient and to the physician about the status of the application, and if it's denied or has a problem, why. There's a whole like IT element of this where there's a patient portal piece so that patients would also be able to log in and track the process themselves. On the one hand, I think that's nice for people who want to, you know, follow along. On the other hand, you know, if you don't feel well with cancer, ideally this should be getting addressed without you having to log in and check up on it. You could be like resting, recovering, enjoying your family. But overall, I think there's an understanding that we have to move away from this very analog process that we have now. So that I guess is going to come online starting in about 12 months. And then there's a bunch of work going on at the state level. Some states are requiring electronic PA, which I think is terrific.

Throughout these bills, there's also some time deadlines on these decisions. So I think having a turnaround time, whether it's like 72 hours or seven days, whatever it is, I think it's good to put those into place. I worry about an unintended consequence will be that if they can't meet the deadline, they would just deny it and you would go to appeals. And again, coming back to my fixation on like, what does the appeals process look like, but I think overall it would be very helpful to have some like, better definition and better clarity.

One thing I haven't seen in these, but I hope that policymakers and advocates will become interested in is I would really like to see some more standardization of these forms across payers. Obviously, the dream would be like standardization and actually like the parameters. But even if we can't get there at least like the paperwork could look the same because there's a lot of duplicated effort in filling out the forms and submitting these. This is really unnecessary, like it should all just look the same. And we keep reinventing the wheel which slows everybody down. And I think there's a huge policy opportunity there to promote standardization that if we have to do this, like at least it could be less painful.

Dr. Fumiko Chino: Absolutely. And I always try to highlight when I think about state level legislation, things like Gold Card Acts to my knowledge have not included any cancer services as part of what you could be gold carded for. At least not, again, not that I'm aware of at the various states where they have passed Gold Card legislation, which is a promising way of facilitating approvals. But so far, cancer patients are still kind of left out of that. Have there been any institutional policies that you've noticed seem like they help with prior authorization?

Dr. Michael Anne Kyle: No. And I think a lot about my research, like who my audience is and its organizational leaders and policymakers. And I would really like to see clinical organizations advocate for more standardization and more process improvement. I understand the emphasis on like we don't like prior auth and we want less, but I think there's an easier win in asking for this system to work better. And I'd love to see some of our health care organizations put their weight behind that.

Dr. Fumiko Chino: I have to say, since transitioning institutions to MD Anderson, I've actually been very pleasantly surprised within our radiation oncology department how streamlined the process is. And I think it's because we had a motivated faculty member who went deep into the prior authorization process and why the plans were being denied, got all of the constraints that would trigger an approval and basically built them into our planning process. So it's been really streamlined, but it was a lot of investment upfront to kind of get it to the point where it is now.

Well, I think we are wrapping up our time together. Do you have any last thoughts about prior authorization or have what we already said has it been disappointing enough?

Dr. Michael Anne Kyle: Well, let me finish on a positive note. I think what's exciting about this is that we've spent many decades on trying to improve the cost challenges in healthcare. We have the Affordable Care Act. I don't think we've yet put the same effort into non-financial costs. And so I think there is a lot of hard, hard stuff ahead. But I think there's also a lot of these challenges I think exist because no one has looked at them yet. Like how much prior authorization is like a strategic decision? And I ask this to everyone, how much is it of it is a strategic decision versus how much is like the manual is lying in someone's cubicle and hasn't been updated in years and if only someone with decision making authority looked at it, they would be like, “Oh, yeah, you can take prior auth off it”? You know, like, I just think that there's a huge opportunity to do better here because we haven't paid it enough attention. So I think we should be hopeful and I want to do better for our patients. Like I want to feel prouder of the healthcare system that I'm a part of.

Dr. Fumiko Chino: 100%. No, I love that. And that's a great hopeful end, which is that with data maybe we can start to work our way out of this. And so that's maybe a siren call for researchers coming online to think about galvanizing yourself to provide data as to what we can do to improve.

Well, thank you so much for such a robust conversation today about such an important topic. So many thanks to both Dr. Kyle and to our listeners for your time today.

For listeners that are interested in advocacy, I would encourage you to visit the ASCO ACT Network where you can send pre-drafted letters to your lawmakers on important legislative issues impacting cancer providers and their patients, things like prior authorization.

You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear from the JCO OP Put Into Practice podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. I hope that you'll join us next month for our next episode. Until then, keep fighting the good fight for our patients.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.

Guest’s Disclosures:

Dr. Michael Anne Kyle No relationships to disclose.

Dr. Fumiko Chino talks with Dr. Aditi Singh and patient advocate Liz Salmi about how this essential tool for documentation could be optimized to be more patient-centered. This discussion will be based off the JCO OP article published in late 2024, “Re-Envisioning the Electronic Health Records to Optimize Patient-Centered Cancer Care, Quality, Surveillance, and Research,” on which Dr. Singh served as the lead author.

TRANSCRIPT

Dr. Fumiko Chino: Hello and welcome to Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability and equity. On today's episode we'll be discussing our friend, the Electronic Medical Record and how this essential tool for documentation could be re-envisioned to be more patient centered. This discussion will be based off of a JCO OP article published in late 2024 called, “Re-Envisioning the Electronic Health Records to Optimize Patient-Centered Cancer Care, Quality, Surveillance, and Research.” 

I'm excited to welcome two guests, the first author, as well as a patient researcher advocate, to the podcast today. Both are passionate about improving how we use the EMR to communicate and provide care. 

Dr. Aditi Singh is an Assistant Professor in Clinical Medicine and Hematology Oncology with a focus on thoracic malignancies, particularly neuroendocrine tumors of the lung. She also serves as the Director of Clinical Informatics for the Abramson Cancer Center at the University of Pennsylvania. Her work focuses on optimizing the EHR to enhance provider efficiency and provide high quality cancer care. She also serves on the NCCN Guidelines Committee for non-small cell lung cancer, thymic malignancies and mesothelioma. 

Liz Salmi is the Communications Inpatient Initiatives Director for OpenNotes. In this role, she helps clinicians, hospitals and the health system understand the changing nature of patient-clinician communication in an era of growing transparency. As a person living with a malignant brain tumor, she is active in research and advocacy to ensure that the patient voice and patient-centered care is prioritized. 

Our full disclosures are available in the transcript of this episode. And we've all already agreed to go by our first names for this podcast today. 

Aditi and Liz, it's so great to speak with you today. I hope you guys are both staying warm. 

Dr. Aditi Singh: Hi. I'm very happy to be here. 

Liz Salmi: Thanks for having me back. 

Dr. Fumiko Chino: Our topic today is about how we make the electronic medical record more patient-centered. To start it off, I'd love to actually ask a hopefully non-controversial question to both of you. What is patient-centered care? How do you personally define it? Are there key characteristics or is it something that it's commonly mistaken for? Or is it like the Supreme Court's definition of pornography - ‘I know it when I see it’? Liz, do you want to take that first?

Liz Salmi: Sure. Yeah. So, I've been living with a malignant brain tumor or a grade 2 astrocytoma for 17 years. And when I first got into this space, I'm a person with a communications background originally, so when I would hear that term, I'm like, “Yeah, of course, patient-centered care - like what were you doing before that?” And then in the last 11 years I've been working in healthcare and the last eight years specifically with the OpenNotes team at Beth Israel Deaconess Medical Center. So, when I would hear that term, I was like, “What were they doing before that?” Like still even more frustrated. So, it to me sounds like jargon, like a bad form of jargon. And I think that there's new words we could be evolving into over the next, say, decade, maybe sooner.

Dr. Fumiko Chino What are those words, actually, just out of curiosity? 

Liz Salmi:  I want to co-design that with patients. 

Dr. Fumiko Chino: I love it. So that's still a work in progress. I love it. 

Aditi, what's your take on patient-centered care? 

Dr. Aditi Singh: I couldn't agree more. It should just be synonymous with good care. It should just be very obvious. It's a no-brainer. In 2025, it's sad to me that when I was thinking about this question, I'm thinking, “Yeah, what did we do before that? What is it called? What is the opposite of patient-centered care? Shouldn't certainly not be provider-centered or like hospital-centered care.” So, I'm all for it. I'm glad that this generation of medical students, nursing students, everybody's going through learning this concept, even though it should really be something just so organic. But I'm glad that we're putting an emphasis on it, that there is no other way. This is the only way of providing good care. The more agency patients have and for them to be empowered to fully participate in understanding their care, fully participate in their care, I think that's what it means to me. 

I think sometimes I see misinterpretations of it in the sense that, well, that means that everything the patient says I have to do as a provider. And I feel like it's a partnership, it's not a restaurant where they're saying, “Okay, I want that. And I just make this up.” It obviously has to be within your professional understanding. You're still trying to do the best for the patient in front of you. But within that, because we know there's so much gray area in medicine, not everything falls neatly in our evidence-based guidelines and algorithms. That's really where all the nuance is and that's where we can do a better job at taking care of people, if we work together.

Dr. Fumiko Chino: Absolutely. I think you said the key word for me, which is ‘partnership’, because it really is. It's not like the patient as a consumer, it's a partnership. And I think patient-centered care for me really emphasizes this concept of shared decision making. And again, yeah, it blows my mind that this is like a newer concept that we didn't really, in the paternalistic world of healthcare, the patient was just sort of an afterthought. It was the receiver of care and not the person who was living with an illness.

Liz Salmi: Just to throw in there, there's a very well-known palliative care thought leader, Dr. Ira Byock, who wrote a book called The Best Care Possible about patient-centered care, we could say that, or ‘the best care possible’. And it's a bummer that ‘the best care possible’ was coined and really developed by a palliative care doctor. And I hope people in the oncology community will pull a page from the playbook of all of palliative care, because to me, all of oncology care should be palliative care and that's disease treatment but also pain and symptom management. So, I just got to throw that shout out to all of palliative care in this podcast. 

Dr. Fumiko Chino: 100%. I feel like there's a lot we can learn from palliative care for pretty much everything that we do in medicine, including enhanced communication.  

Aditi, do you mind giving us a quick overview of the article that your multidisciplinary team published in JCO OP last year about how to make the EMR both more patient-centered but also work better for research and surveillance? I'd also just really love to hear about how you got interested in this topic altogether.

Dr. Aditi Singh: Yeah, absolutely. So, the National Cancer Policy Forum convened this workshop in 2022. It's a two-day workshop which focused really on improving EHRs for oncology care, surveillance and research. And we had discussions and talks from various stakeholders, experts in their fields, just putting our heads together and hoping for a better way than what we have. I think there was general agreement that we are very glad for EHRs as an advancement over paper records, but I think we all kind of felt that EHRs haven't really realized their full potential in all the great care that can come through them. And we all identified certain challenges that EHRs have brought with regards to EHRs really being formulated as primarily billing scheduling tools in the 1970s, and now it's this all-encompassing system that we use to do everything. All of our interactions are through the EHR, kind of this like thing that comes in between, sometimes we feel, like us and the patient. As providers, we talk to different stakeholders like oncologists and providers, patient advocates, patients, the federal agencies, EHR vendors. So, all of us kind of coming together, researchers, quality improvement advisors, to really figure out what are the challenges and what we can do moving forward to get to a better place. And I think my own personal journey on how I got interested in EHRs and how to use them to kind of harness their power, so to speak, to provide better care and to improve provider wellness was another one. 

I trained in India. My medical training was in India, where the system is fairly traditional and paternalistic. And then moving to the US and seeing just a lot more time spent with patients and involving them in general, there's a lot more we can do. But just coming from a place where there wasn't as much of it, it was really cool seeing that. And then through my training, just watching my colleagues struggle with how much we had to interact with EHRs. I think none of us went into medical school thinking that I'm going to sit in front of a computer all day and spend less time actually talking with my patients or always have this thing in the background when I'm talking to my patients. And so, I think seeing my colleagues and myself struggle through that and hoping for a better way to just achieve that “work-life balance,” or doing what you love without getting bogged down by the administrative tasks that just keep piling up. 

And then I think my own life and my own struggles with fertility, having a late miscarriage, having a traumatic birth, and then now being a parent, once you're on the other side, it changes the way you think about these things. And I think being a patient can be so lonely and so scary. Here we're talking about cancer, and you're so vulnerable in that moment. Even as a parent, I say, you know, all your medical training goes out the window when you have a loved one that's sick. You both have beautiful stories on how you've learned from your own experiences. So, I think that was truly telling, that it changes the way you see the person in front of you once you've experienced it yourself. So, I think that's how I got into this space to hopefully move forward.

Dr. Fumiko Chino: There's a quote from the paper which was, I thought, was very telling, which was that “EHR development was driven by regulatory requirements rather than a focus on the user experience.” So that's either providers or patients. They're both using the EHR, correct? It was not really built for either of us on either side of the computer, basically. And so, I love the idea of how there could be steps along with each kind of stakeholder to make things a little better. 

Liz Salmi: One thing I didn't necessarily see in the paper was that patients are actually the biggest user of the EHR through the patient portal. And so that needs to be acknowledged as well. And as you said, Aditi, like the user experience of these portals, is not great for clinicians and it's terrible for patients as well. So, I think both patients and clinicians can come together to co-design the future of that user experience for sure.

Dr. Aditi Singh: 100%. 

Dr. Fumiko Chino: And that actually segues directly into my next question, which is Liz, to kind of start off by saying, congratulations, you just won this recent award from the Society for Neuro-Oncology. And I know that your day job and your personal passion is to improve communication between providers and patients with this kind of central tenet that patients should be both encouraged and supported to be fully engaged with their medical care. Do you mind just kind of briefly discussing your career arc and how this really intersected with your diagnosis and your medical care for a malignant brain tumor? I know you mentioned a little bit already. 

Liz Salmi: Sure, yeah. None of this is pre-planned. It's just all happened. I think clinicians perhaps come into medicine, maybe not all of us, but “Oh, I want to be a doctor.” And then you kind of figure out your path along the way and how you become leaders. I mentioned earlier that my background originally is in digital communications. And then at age 29, I had a massive grand mal seizure and then found out I had a brain tumor. And then jumping ahead, you know what I'm doing today and I can fill in the gaps. But today I work on the OpenNotes team at Beth Israel Deaconess Medical Center, which is one of the Harvard Medical School teaching hospitals. But the OpenNotes team, we've got researchers around the country and around the world, are really focusing on how transparency and transparent communication improves care. And so, when it's some defining words, we say when a clinical note is shared with patients, they become an open note, lowercase. And then our team is OpenNotes, a proper noun. And so, for the last 12 years, and this is before me, I've just been the last eight years, but for the last 12 years, we've kind of created this new field that's focused on research around how open and transparent communications improves relationships between clinicians and patients. And we just remain motivated by evidence that shows that when healthcare professionals offer patients and families ready access to these notes, how that improves actually safety of care as well, because you can spot errors in the record or, you know, just have more open dialogue.  

And so how I got here, grand mal seizure, communications, digital design. Really just sometimes people become patient advocates quite often because maybe they had a bad experience, a terrible experience, and they want to fight the system or co-design a thing with the system. I had the opposite experience. I had great care. I just was so curious about what was going on from a neurological perspective, from a neurosurgery perspective, move along around the lines. And then things started to change when I became a patient. It was the ‘do not google the information in your records’ era. We're talking about the 2000s and then late 2000s.  

And then my magical change moment is when I had to change health systems and request a copy of my medical record to like the new location. They said, “What do you want from your record?” And I was like, “All of it?” I don't know what's in it because I had really never seen it before. And so, God bless Kaiser Permanente Northern California for really giving me all of the record on like a DVD. And I had to pay for that. And so, I, of course, as a curious person, just threw that DVD into my computer and started looking at a 4800-page medical record. And I was like, “Oh, my gosh. They've been talking about me this whole time.” I'll try to summarize it now, but I just didn't know that notes were part of the thing. And so that ultimately launched me to the OpenNotes team, the OpenNotes journey. Finding out that researchers at other hospitals are starting to study that. And so, I was like, “How do I get involved in that movement?” And so here we are seven, eight years later for me being part of the team and they're so wonderful academic clinicians, it's all about teaching and like training the next generation. So, I've been taught and trained and now I'm involved in the co-design research. 

Dr. Fumiko Chino: You know, I think you're underselling yourself because you as a patient PI, I think you've been on the ground floor of this concept of we need to be co-designing research around the patient experience. You've won, as part of your team, multimillion dollar grants to study quality of life and even this, I feel like this most recent award and I am not trying to paraphrase the SNO Annual Meeting, but I think you had asked, “Oh, is there registration or something for patients?” And they're like, “No, this isn't for you.” Advance six years later and they're giving you an award! So, I feel like you've been on the ground floor of all of this very important move towards collaborative work with patients.

Liz Salmi: Thank you for highlighting that. Yeah, I think what I've learned in this experience is if someone tells me ‘No’, I want to work harder to prove them wrong.

Dr. Fumiko Chino: It's that punk rock mentality.

Liz Salmi: There we go. 

Dr. Fumiko Chino: Now, there's been a lot of consternation from both institutions and providers regarding the release of test results immediately to patients via the 21st Century Cures Act. These releases may actually even come before the primary team has been able to discuss the results and their clinical context with the patient. And I know a 2023 JCO OP article showed that 75% of surveyed oncologists felt like the immediate release of clinical information had a negative effect on their practice and/or their patients. I've certainly personally seen how the immediate release seemed to have fostered some anxiety for some of my patients. And yet I truly believe, and this is a direct quote from the manuscript, “Health records fundamentally belong to patients.” Liz, I'd love to hear your perspective on this because I know that you were a first author of an ASCO Education Book. The chapter was called “When Bad News Comes to the Portal: Strengthening Trust and Guiding Patients when they Receive Bad Results before their Clinicians.”

Liz Salmi: Yeah, that was a fun one to work on. It's open access, I believe, so people can go find that. But in that book chapter, we cite a couple of papers, specifically one of the papers and anyone can look this up. It's in JAMA Open, so it's open access. But well, we cite our own paper or I cited our paper with wonderful people. I was like fourth author or something like that. So, it's not just me. Saying that, all of those caveats, we cite this paper called “Perspectives of Patients About Immediate Access to Test Results Through an Online Patient Portal.” And what we did with that study is we surveyed patients at four sites around the country and really, we learned, despite clinician reservations, about getting immediate access to these test results, 96% of patients still want immediate access to the test results. And that stayed true even among those who received non-normal test results. Could be scary. And we actually asked them, "How did this make you feel? Were you more nervous? And they said, “Yes, but we still want it immediately.”  

Knowing that and knowing that we can't put the genie back in the bottle for Cure's rule and everybody has decided people should have access to their information immediately, there are benefits to people having access to the information. So, if it's a note thing, they can find errors in the record. When it comes to their test results, they can plan ahead. And I think in the oncology perspective, I believe for folks who have an active cancer diagnosis and they kind of understand their current experience like I do, I see these immediate results, I see the immediate MRI results and I'm like, “Yeah, I still know I have brain cancer. That is not surprising to me.” But I think where things are kind of troublesome, is like a new diagnosis or somebody sees something through their primary care, general care setting and then something, probably an imaging result says something worrisome and then the patient is going to Google or use ChatGPT to kind of understand their situation. And I think that this is a situation where, and this was also mentioned in the ASCO book chapter where Daniel McFarland coined the phrase, ‘truth jumping’. What do we do if people have access to all the information, they feel unsupported in their care. And I think that there's a way to mitigate that, especially in like primary care settings where the ordering clinician of that test, whatever that test is, can really create some anticipatory guidance around it and say something very simple when they're ordering the test and I'm pulling a quote directly from a book chapter and other things, but it's like, “I am ordering a test. You might see the result before me. You have a choice, patient. You can look immediately or wait to hear from us. And what questions do you have?” So really laying, “Here's what's happening. Now, I'm ordering the test.” And so, it creates context around. 

Dr. Fumiko Chino: Aditi, do you have any additional thoughts about this? About, for example, how to release test results effectively? How could it potentially help or harm their relationship with their oncologist? 

Dr. Aditi Singh: Yeah. Before the 21st Century Cures Act, we all had the same reservations that, “Oh, my gosh, having cancer is hard enough! Hearing it through the portal and not through trained physicians or providers who know how to break that news with some empathy and context on immediately following it up with what's next is going to be so jarring for patients. It's going to create so much anxiety.” And I kind of still believe that. Yes, I've seen people who've gotten their results and it has created anxiety and it has been stressful. But at the same time, I think that's their choice. They get to decide that. We're all adults here. Obviously, it's different when you're making a decision for someone else. But we're taking care of adult patients who get to choose. And now you can give, just as Liz said, actually setting expectations as the ordering clinician and saying, “I'm going to order this,” and, again, as an oncologist, most patients, like Liz said, it’s really about, “Is my disease progressing? Is it back?” And patients have understood that they can read that if your impression says, ‘no concerns for cancer’, you kind of get that - they are like, “Okay. I'm good.” Or if there's something concerning, you understand that, and it's not mind blowing. You kind of know, well, there was a percentage of chance that this would be good or bad. I think setting expectations, especially when we think it might be a new diagnosis, that this could be something that is as bad as cancer. If you are getting a colonoscopy, a screening colonoscopy, and we find something there, and the pathology is looking for abnormal cells or cancer cells, you can opt out and say, “I don't want to look at this,” or you can. The other thing I encourage patients to do is just kind of see when their next appointment is scheduled because, I for one, as a patient would hate that I see something online and now I'm not seeing my provider for the next two or three weeks. So, giving enough time, a reasonable amount of time for the test to be read so that I am prepared, so I have had a chance to look at it for the patient so we can have the best discussion. 

But at the same time, once the patients understand that, and I think many patients do now, and I have both types of patients, some people say, “I don't look at it until you tell me.” And there's people who look at it and then there is a lot of sometimes back and forth and we try to set these expectations that if this is something bad, if it's something really bad, where I need you to come to the emergency room right now, you're going to be hearing from me. But at the same time, it's nice that patients have that agency where they can say, “Hey, I just want to make sure I didn't get missed because I know you get a lot of test results and I hope you saw this, but this doesn't look good.” You're empowering patients again to fully participate. And if you are someone who finds it helpful to ChatGPT or Google, from reliable sources- that's another thing, as a provider, I can give them reliable resources like, “Hey, this is a good website. This one, not so much. You can look at it and then you can come prepared for your visit and say these are the things I looked up. I have some questions now that I can better participate in this conversation.”  

So, I think in general I firmly believe that the patient health record really does belong to the patients. They get to decide how and when they want to look at these things. But just as providers, we can help them set appropriate expectations and boundaries. And we sometimes get a lot of back-and-forth messages and we have to say, “Hey. This is non-urgent. I promise I'm going to talk about this at our visit. But just to provide good care to all my patients, I can't be in a back-and-forth kind of text message about this result.” 

And then the other thing is that we can now use cool new technologies like natural language processing and these large language models where we're looking at- one of the things we get a lot is, “Oh, my God. My esophagus has collapsed.” Because that's the normal way for the esophagus to be in the body unless you're eating. So, it would be nice if maybe we could have cool technologies where someone can hover over their test result and kind of translate this to me in something that a layperson can understand who's not in medicine. That includes that your esophagus is collapsed, which is its natural state. Nothing to worry about. So, some of these things we can do better with just technology.  

And I think one other thing I'll say is the onus of all of this can't only be on the provider. I think we need to make sure that the providers are supported to do the right thing because it is the right thing to provide patient-centered care and give patients the answers they want and help them through their journey of whatever diagnosis they have. So, if you have competing interests where there's profit-based companies telling you, “You need to fit in more patients and you need to see 30 patients a day and you need to make sure you bill appropriately.” Because none of us are thinking that way. We went into medical school to help people and interact with people. But if you don't give providers the time, they need to have these discussions, the support for some of these questions to be handled by their staff and it can be a triage nurse who can then immediately call the patient and say, “Hey. Don't worry. Dr. Singh looked at this report and she said that this part is totally fine. She's going to talk to you more about it,” but you have to have a whole team that helps the provider do that for them. 

Dr. Fumiko Chino: One thing I think that struck me about your article was this idea that by providing more support to providers, so by making the electronic medical record system work better for providers, you are actually making it more patient centered. You are basically loosening up that chokehold that sometimes the EMR has on providers to actually give us more time to have those difficult conversations or to make those phone calls and not just to be constantly documenting. 

Now, Liz, I recently read one of your many research articles that you're a co-author on. This one was in a Medical Informatics Journal from 2021 and it showed that after OpenNotes implementation, oncologist notes overall seem to become a little longer and easier to read. Yet some consistent feedback I hear from patients remains that the use of abbreviations and medical jargon stymie their understanding of their notes and their results. Do you have any thoughts on concrete steps that we can do to improve the use of the EMR as a tool to provide patient-centered care?

Liz Salmi: Yeah, for sure. How do we make these portals more friendly? I mean, they're not friendly for the docs and clinicians and they're not friendly for the patients. I mentioned earlier, the biggest user of the EHR through their patient portals is patients, and so these portals have not been designed well at all. Things we can do to make that portal easier for the patient user, knowing that now we have access to this information, we're seeing our test results before our clinicians and then we're going to message our clinicians and ask them questions. Some health systems are actually implementing penalties on patients. Like they're going to get charged for these patient messages and that's still up in the air. But with that in mind and all of that context and the amount of information that's available, some concrete next steps are to get people on the portal before something bad happens. So the proactive thing, people are used to using these tools and then from there you kind of learn the rules of the road or like what's okay or not okay or you kind of learn a bit about, “I know this question could be better asked in the clinic as opposed to through the portal because I've been dinged in some way.” And it's unfortunate to get dinged in some way through those portal things. Or it's like if you keep asking me more questions, this becomes some sort of a digital visit and you might get charged for this. So, like figuring out that murky space, I feel like I'm talking about in a horrible way, but that still is like a place where getting things figured out. 

And then the thing is like the things that people like to use, things like social media are sticky and are pretty well designed. The patient portals have not been well designed. Can we pull a page from the playbook of digital tools that are working well that people like? And so that's like another ripe opportunity for co-design. And the people who build the patient portal tools, the people, the EHR vendors, I go to their conferences from time to time. Sometimes I have an abstract that gets submitted and then I get to learn what those vendors are doing and they don't partner with patients in the co-design of those things. I'm just talking about they in general but you can kind of guess who I'm talking about. But they are early phases of you know when I am at the conference and I'm the person who stands up and asks the room, “Did you involve patients in the co-design of your tool?” And they're like, “We're figuring that out.” And so, it's sad that that hasn't happened. So, we could say it's sad for the clinician side but definitely sad from a patient user side especially if like that some of the systemic issues from a clinician strife perspective is, “Ah, my patients are over messaging me.” 

And then another thing is we could bake in, we should be doing studies of how people are, especially people with cancers and kind of scarier conditions that make you message more, bake in things about studying what kind of maybe AI related tools to help us when we're in those kinds of scary situations. So, you know, shout out to our team as we are kind of focusing on some studies on that right now. But of course, the study is in progress and I would love to tell you the results right now and then I can't. So, it's like how do you kind of give really from a dissemination perspective how do you kind of say, “We're in progress, this is what we're learning so far.” And so, from the ‘what can we do right now’ perspective as all of these things are going on, the Cares Act has happened, patients can see their test results. But something that has been well studied at least in the OpenNotes universe is we know from 12 years of research and 12 years of studies on the concept of when patients read their notes, they better understand their care and are more likely to follow up with what their doctor said, there's a whole body of work there. And the big tips are to patients and things you could communicate to patients are after the visit's over, reread your note. That is the concrete conversation. That's everything we talked about today. Read it. Encouraging reading your notes after a visit. And then another tip from Liz, super patient advocate, is before your next visit, read that last visit again. It may have been three months, it may have been six months, it could have been a year. Read that before your next visit. Because I know hopefully the clinician is doing that like 10 minutes before the visit. But it's like I'm going to read that and go, “Oh, this is what they said. I totally forgot that. I actually didn't do that or I did and it hasn't been fixed.” So, the idea of reading the note and then reading it again later because that's what the clinician is doing as well. So, it really kind of puts us all on the same page. 

Dr. Fumiko Chino: I love it. Aditi, I'd love your perspective on this as well. As a provider, as a researcher, I think fundamentally we often don't think of notes as being education tools for patients and we need to balance this patient-centered care with other advances. Even in your paper, we're trying to get advances in quality surveillance and research. But again, there's this concept that maybe those advances in those things can be very patient centered as well. Where do we go next for this?

Dr. Aditi Singh: Yeah, the culture shift. Because I know a lot of people have said, well, these notes traditionally were not really patient facing. So, we would write a lot of things and sometimes we would take it just too far where sometimes, like I can't understand what my colleague in ophthalmology is saying. I've tried to interpret sometimes hearing tests and I was just like, “Wow, I don't know your abbreviations. Mine are different from yours.” And so, I think it's a good thing that we're in general saying that these notes should be more readable because for everybody, even within the medical community, I think there's been an issue with note bloat. And some of our notes, especially oncology notes, and there's been research on this, are just some of the longest, not necessarily the best quality, notes, but just very long where it's just really hard. When our patients get admitted to the hospital, sometimes a hospital team has a hard time understanding what was going on outpatient. Your note goes on for 30 pages and I can't find out what I need to find out. And same thing for patients. So, I think, in general, it's a good thing to just push increased readability and just teaching medical students and us, as hard as it is to change. But it's a good reminder for me and say, “Hey, I wrote this. Does this make sense to someone who doesn't practice oncology?” And if it doesn't, how else could I say it where it doesn't necessarily take me an extra hour finishing my note, but it's still succinct. It's not going to have all the education that patient needs. I'm still going to have supplementary material that is very specifically patient facing because it will have more information. And then I still have my people resources, my human resources that are going to do a, say, chemo teach visit for someone who's starting a new therapy. And I have my pharmacist who's going to do that, too. But how do we use all of that so that the patient in front of me feels as prepared as they possibly can to get this treatment, go through the scanxiety that comes with scans and go through this journey feeling that they have some sort of– We're all looking for that sense of control where we have none in some of these situations. So just helping each other out this way.  

So, I think, yes, absolutely, need to make our notes more readable. We can do some of it ourselves, some of it our technology does. So, we have an autocorrect in our EHR that I use heavily and I still sometimes will write in shorthand and it just auto corrects all the words that I'm used to writing in and it just fixes all of that for me. So, use the technology. And some things we're learning too, and we talked about this in our article too, how certain things we said were using stigmatizing language, sometimes inadvertently, and how some of these biases get perpetuated. And we've just been saying that and now someone said it in a different note that got copied and pasted and now we've just perpetuated this thing that was completely inaccurate about the patient. So absolutely, more power to patients to read that and say, “Uh-uh, that is actually not what I said. And actually, can we have a meaningful conversation on what this meant?” So I do think we can do better as a community and I think if we and the EHR vendor, if they continue to use these newer technology, a lot of us are testing ambient listening and I think that'll be really cool because if I can just sit and look at my patient and not have to type anything, and I have this AI tool that kind of summarizes our interaction and makes sure that we put in all the important information in that patient's note. And then it's a great reference, like Liz said, for the patient and for me when I look at that note next time.  

Because there's also research that's shown what the patient says and what you actually type is often you just filter out so many of the things because I'm in my medicine brain, you're filtering out as people are speaking because you're also trained to recognize the worst-case things and, “Not dangerous, not dangerous, not dangerous. Okay, I'm going to write the one that sounds- chest pain. I'll write down funny tingling in your toe that happens like once every once in a while.” I keep on going because I need to also focus on things that I think I can triage in my head. But this is cool. This way we get to hear the whole story and I think have more open-ended discussions as opposed to these short, “Do you have chest pain or not? Constipation, yes, or no?” But actually saying, “Hey, Liz. What's your story? Very different question. 

Dr. Fumiko Chino: And I think that just to kind of point to this concept of the patient reported outcome and the tingling in the toe that does happen every now and then but has consistently happened for the last 10 years. I feel like PROs can really potentially actually capture that better. 

I would just like to give a little last time at the end in case there's anything that we didn't touch upon that you feel like is really relevant or pressing before we say goodbye. 

Liz, anything that we missed?

Liz Salmi: Not a miss, but just a quick thing is a little bit about LLMs or AI tools in the exam room. And I just want my doctors to know that I'm also using those tools. And it'll be an interesting next few years as the patients are users and the clinicians are users and I don't want them to just talk to each other. So how do we design this stuff together?

Dr. Fumiko Chino: Sometimes I feel like patients and providers are just on the world's longest blind date. We're just trying to find enough about each other to have a meaningful relationship.

Liz Salmi: That's cute. I love that. 

Dr. Fumiko Chino: Aditi, any last thoughts from you? 

Dr. Aditi Singh: I love this quote by Ram Dass where he says, “We're all just walking each other home.” We're a team. That's how I think most of us oncologists think. I love my patients. I want to do what's best for them. I think most of us are that way and I wish for our regulators, our payers, our healthcare systems, to all get on the same page so that- we want more of this. We want more of this interaction, that mutual respect and trust that is just invaluable. And we want all of those other stakeholders to come together and help support this. And I think that support’s the biggest mission here.

Dr. Fumiko Chino: I love that. What a great way of ending this conversation. Thank you so much for this wonderful conversation. Many thanks to both Dr. Singh and Ms. Salmi, as well as our listeners for your time today. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice Podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. And I hope that you'll join us next month for Put into Practice's next episode. Until then, stay safe.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  

Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.

Host Dr. Fumiko Chino sits down with co-editor and health outcomes researcher Dr. Ryan Nipp, and contributing author Dr. Kelly Shanahan who is living with metastatic breast cancer to have a candid conversation about financial toxicity, the lived experience for patients, and what we can do to move the needle on affordability in cancer care.

TRANSCRIPT

The disclosures for guests on this podcast can be found in the show notes.

Dr. Fumiko Chino: Hello and welcome to the inaugural episode of Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity. 

In today's episode, we'll be highlighting the special issue of JCO OP focused on financial toxicity. I'm delighted to serve as an editor for this special issue, and I'm overjoyed to welcome two guests who were instrumental in creating the issue. The first is my co-editor, Dr. Ryan Nipp. He's a Medical Oncologist focused on GI cancers at the University of Oklahoma Stephenson Cancer Center, where he also does cancer outcomes research. I'm also pleased to welcome Dr. Kelly Shanahan, who is an author of a narrative piece for this issue. Dr. Shanahan was a practicing OB/GYN in Lake Tahoe, California when she was diagnosed with stage 2B breast cancer in 2008. She has now been living with metastatic breast cancer since 2013 and serves as a patient advocate and research advisor. 

Our full disclosures are available in the transcript for this episode and we're all already agreed to call ourselves by our first names for the podcast today. 

Kelly and Ryan, so great to speak with you today.

Dr. Kelly Shanahan: Likewise, Fumiko. 

Dr. Ryan Nipp: Thank you so much.

Dr. Fumiko Chino: To start us off, I'd love to just set the scene about financial toxicity, our topic. Ryan, do you mind sharing an overview of financial toxicity, what it is, what it isn't, and how you got involved in this type of research?

Dr. Ryan Nipp: Absolutely. Thank you. So I always start with the idea that the NCI website, I remember when this came out a few years ago, they provide some helpful information on this topic. The definition that they provide I think works nicely. It states that financial toxicity describes the issues patients may have related to the cost of medical care. The high cost of medical care, in addition to the cost for missed work, loss of employment and travel and lodging for care, can cause financial problems and may lead to debt and bankruptcy. Financial toxicity can also affect a patient's quality of life and access to medical care. For example, a patient may not take a prescription medicine or may avoid going to the doctor to save money. Research also suggests that patients with cancer are at risk for experiencing financial toxicity potentially greater than people without cancer or other medical issues. Financial toxicity is also sometimes called financial burden, financial hardship, financial distress, financial stress, economic burden, and economic hardship. So it goes by a lot of different names. 

Throughout my career and my research to date, I developed an interest in financial toxicity as I'm particularly interested in improving care delivery and outcomes for patients impacted by cancer and this continually became an issue as I was growing and training in oncology, noticing that the financial toll of having a cancer diagnosis can be remarkably problematic and concerning for our patients. Thus, I wanted to find ways to study this issue and ultimately develop strategies to address the problem. 

So just to give a little bit of background on the current JCO OP special issue, we wanted to do this special issue for numerous reasons. We're fortunate to work at JCO OP or work with JCO OP, JCO Oncology Practice which has a unique interest in this topic. We've been working to address this issue of financial toxicity throughout our careers, I say me and Fumiko, and we felt that the current time represented a unique opportunity to take a look back and see what progress has been made, also, what problems are persisting. We are extremely proud of this special series as we've had numerous unique viewpoints captured and I think this series provides a relatively comprehensive overview of the current state of the science in this field related to financial toxicity and oncology. 

And looking back over our notes over the past couple of years, while we were planning this issue back in the summer of 2023, we had wanted to have a broad array of articles specifically focusing on the state of the science of financial toxicity, understanding the health insurance landscape, health policy issues related to this, cost of care discussions, social determinants of health, financial assistance programs, and financial navigations. We also wanted some unique perspectives on financial toxicity with regards to geriatric oncology, a global and international perspective, and we wanted to have as many articles as we can relate to the patient perspectives on this topic, which we’ve got very fortunate for. Specifically we wanted one to give an overview of the foundational work in this field. Number two, highlight knowledge gaps that still exist. And number three, compel the field forward to encourage interventions and innovations necessary to move oncology into a more equitable and affordable space. We are blessed to have so many phenomenal colleagues that were willing and able to share their experiences, expertise and insights for this special issue. So thank you. It was a long winded answer, but I'll stop there.

Dr. Fumiko Chino: I Love it. I 100% agree with you. I feel so blessed to have worked on this issue and it really is sort of where we are now, how did we get here, and what the future should hold, how can we be doing better for financial toxicity.  

Now, Kelly, your piece “Debt or Dying?” was a real highlight of the issue for me. Do you mind speaking on the lived experience of financial toxicity and how costs have really unfortunately driven some of your treatment decisions and your options? 

Dr. Kelly Shanahan: Yeah, thank you Fumiko. Thank you, number one, for inviting me to contribute to this issue and for your kind words about my piece. I come from a place of privilege. I was a physician when I was diagnosed, but both with early stage and metastatic cancer. Yet I still suffered significant financial impacts. When I was early stage, I had the option, obviously, of either a lumpectomy with subsequent radiation therapy or a mastectomy. Well, I live at Lake Tahoe where we have zero oncology services at my end of the lake. And so for me to have a lumpectomy, I would have to drive 45 minutes to an hour each way, five days a week for radiation therapy, for, at that time, five to seven weeks. We didn't have accelerated courses of radiation back in 2008. I had a then nine-year-old and I was in solo private practice. So if I had chosen radiation therapy, that would have been time away from my practice, loss of income, having to make sure my husband or somebody else could pick up my daughter. So I chose to have a mastectomy and that was my primary reason for choosing that type of surgery. 

Then five years later when I was diagnosed with metastatic breast cancer, again, no oncology services in my town, except for someone I was ironically subletting my office to one day a week who recommended combination IV chemo, hoping to get me closer to the starting line so I could perhaps live longer. My daughter at that time was in 10th grade, a sophomore in high school, and I would have done absolutely anything to try to make it to her high school graduation. So I did the chemo which included a taxane, which left me with permanent chemotherapy induced peripheral neuropathy. 

Now, it's a little challenging to be an OB/GYN with numb fingers because I know I wouldn't want somebody trying to catch my baby or wielding a very sharp scalpel over my anesthetized body who had trouble feeling their fingers. So I had to stop practicing medicine, which was a huge, huge impact. I will remain eternally grateful to the men I started in practice with way back in 1991 when I finished residency for insisting that I get a disability policy because that is the only reason that my family did not have to declare bankruptcy was the fact that I had a long term disability policy. But it still made a lot of impacts on things we chose to do. I remember I was diagnosed prior to the advent of CDK4/6 inhibitors and I was diagnosed early stage, prior to the advent of the Affordable Care Act, which was a whole other thing. But I remember thinking, “Oh, my gosh. If I have to go on a CDK4/6 inhibitor that's going to cost $15,000 a month, I'm going to have to pay a 20% co-pay.” And that's a choice between putting that towards my daughter's college education. I would have chosen not to take that medication. Those are huge things, and that seems cheap. 

Now, I am currently on a medication that was approved a year ago that is $28,000 a month. Fortunately, I have Medicare due to disability. I'm still not quite old enough for Medicare, that covers my expenses. I met that $3,400 medication deductible within the first month of being on that medication. But that has eased the financial burden. I also chose to participate in a clinical trial last year when my cancer progressed. And I live in a ski resort town 200 miles away from a major academic medical center. So it was 200 miles each way to participate in this clinical trial. And again, I had the wherewithal to be able to put a hotel or an Airbnb on my credit card, to pay for the gas and then wait for reimbursement. Not everybody can do that. We wonder why we can't accrue to clinical trials. We wonder why we don't have the diversity that we want. Well, these sorts of financial issues are part of the reason.

Dr. Fumiko Chino: Thank you so much for that overview of what you've had to deal with during the course of your disease treatment and that realization that, ‘oh, this is with privilege’ that I know what struck a chord with me as a cancer caregiver. 

I was brought into the field of financial toxicity as being the primary caregiver of my husband. He was diagnosed with cancer, again before the Affordable Care Act, and we had these caps on his health insurance payouts. And so we ran up against his lifetime payout cap and essentially had to pay everything out of pocket after that. And even just for people with long disease courses or who were treated before the Affordable Care Act, they've seen a huge sea change in terms of financial toxicity. But sadly, the Affordable Care Act hasn't made actual cancer care necessarily more affordable as we continue to produce more effective treatments, but they come at these great expenses. And I think we are now at, I would say a liminal point where we're at accelerating drug discovery and also accelerating costs. 

One of the reviews in this special issue focuses on the social and legal needs. Things like housing or food insecurity, transportation barriers, unemployment and psychosocial needs. They have a bidirectional impact on financial toxicity. And Dr. Hussaini and his team really put together a nice overview on this topic for the issue. Kelly, I know you've already spoken a little bit about this, about the transportation barriers, about the difficulties being unemployed. Again, coming from that position of privilege, can you talk about how hard it's been to even just navigate the healthcare system even with your incredible knowledge base as a physician expanding on what was hard for you, if it might have been harder for other people within the larger community of people with metastatic disease?

Dr. Kelly Shanahan: Yeah, I mean, I'm a physician and I know the healthcare system and I had a hard time figuring things out. And some of this, I realize now, when I was a practicing physician, I didn't know what things cost because what things cost depends on what your insurance is. And that's true of the cost of an office visit, of a procedure and of medications. That was challenging as a patient knowing who to call to find out to get a patient assistance program. And then when you have Medicare, again, whether it's because of age or because of disability, you hear all these things about, “Call company X if you need financial support for our great drug,” but that's not accessible if you have a federally funded insurance. So I think that was really challenging to figure that out. 

Fortunately, a great clinical pharmacist at UCSF really helped me with that process. And I think that's something that we don't realize as patients is there are other resources. Our doctors don't know all the nuances of the financial aspects. If you are being treated at a larger academic medical center, there should be a financial navigator. But considering the fact that most people with cancer are treated in the community, and especially if you're treated in a private practice versus one that might be affiliated, let's say with a community hospital, they may not have an oncology social worker, they may not have a navigator. And I really wish there were more programs available like the one at Levine Cancer Institute that has a financial navigation program, a multidisciplinary program to help patients. There are a lot of resources available to patients.  

I am on the board of directors of METAvivor. Our primary focus is raising money for metastatic focused research. We fund research, but we also offer resources that we can connect people with on our website, connect them to places where patients can get financial help. There is a fabulous organization, the Lazarex Foundation, which used to provide financial support to help people do a clinical trial, support for housing, support for transportation. And I know their funds are limited and that has sort of gone by the wayside, and that's really unfortunate because we want more people to participate in trials.  

And I think we have to move away from this, “Oh, yeah. We, the pharmaceutical industry, the sponsor of the clinical trial. We’ll reimburse you.”  Number one, they do not tell you that upfront. I knew that. I know that from the relationships I have with some people in the FDA. I know that that is allowed. So I specifically asked about that. But most patients don't know that. And I think any patients that might listen to this, if you're contemplating a clinical trial, upfront say, “I know that reimbursement for my travel related expenses and trial related expenses are allowable under FDA guidance. So how are we going to do that?” 

But I also think that this needs to be not retrospective, not a reimbursement, but for a lot of people it needs to be an upfront payment. Even things like to cover the Uber for them to get from where they live on one side of a major city to the cancer center on the other side. So we need to do that. And recently, at the San Antonio Breast Cancer Symposium, in a session for advocates with the FDA, I asked that question: Does the FDA preclude payments before the fact? Do you consider that inducement? And the answer was “No”. There's no rule that says you can't do that. So again, we as patients need to be educated that there are resources available to us and don't take ‘no’ for an answer.  

Dr. Fumiko Chino: I love all that information. And I know certainly when I was a caregiver, when my husband was sick, we had evaluated all the clinical trial options and found one that was potentially an option for him in California. But the travel expenses were too great for us to overcome the upfront cost because at that time he was out of work, I was out of work, we were both out of work, we had no income coming in. And so those travel expense barriers were one of the main reasons why it was a non-starter to even think about the clinical trial enrollment for him. It's just depressing to think that that could have made a difference. But I know that clinical trials work. That's how we discover new treatments.

Dr. Kelly Shanahan: Yeah, and the more people that participate and the more diverse a population– If the only people doing clinical trials are old white women, then how do we know it's going to work for young black women and men or other ethnic groups? We need diversity so that we know how the drugs work, what side effects they have in diverse populations.

Dr. Fumiko Chino: Now, Ryan, I want to pull you into this. What have you found can be helpful to help assist patients who may be struggling with their social or legal needs or even just having difficulties making ends meet?

Dr. Ryan Nipp: Yeah, Kelly, I had worked in the past too with Lazarex Foundation and found them to be phenomenal and the opportunity to get more patients onto clinical trials was a no-brainer and such a valuable resource.  

So I think for this question, I do love this question, I think it depends as Kelly was kind of hinting at too. It depends on insurance, depends on the person, depends on the specific needs. But again in thinking about this, I think there's some growing evidence supporting things like financial navigation. Like you said Kelly, not every place has it. I'm actually very fortunate now at our cancer center in Oklahoma, we do have financial navigators and I always thought that was extremely forward thinking for them. We also have great social work assistance, knowing that that's a limited resource, but we have amazing social workers which I often sometimes get their expertise and help for this. There's some research out there showing that financial assistance with things like travel, lodging and co-pays could be beneficial for our patients. Again, trying to find those resources and is it sustainable? That is a tough question. 

We also have an article in this special series focused on financial assistance programs by Dr. Raghavan which is phenomenal. It's an editorial on this topic I would encourage people to look into when this comes out. I've also just lastly admired recent work that shows that there's an intervention that, I think, I'm not quite remembering where it was tested, but it's a financial hardship screening intervention where they were asking people about financial hardship and then over time were able to find that by just asking and then bringing in whatever resources might be available, this could address the issue of financial toxicity in that study and it was an extremely impressive compelling outcome with that kind of a model. What I think is the future is that we need to continue to see those types of models put into routine practice and how can we actually implement those in our day to day practice. But that to me was very promising when that came out in recent years.

Dr. Fumiko Chino: Absolutely. I think you're referring to Dr. Blinder's piece in JCO from last year.

Dr. Ryan Nipp: Yes.

Dr. Fumiko Chino: Dr. Blinder was one of my amazing colleagues at MSK before I transitioned down to Texas. 

Dr. Kelly Shanahan: Yeah, and Dr. Blinder is working on a new proposal. I am one of the advocates on that proposal again about the financial screening. And again, just even asking the question can make a difference. 

Dr. Ryan Nipp: Yup.

Dr. Fumiko Chino: Absolutely. I know you both kind of pointed out that there are limited resources, but this idea that it's sort of depressing that someone who might be in need will not actually get the assistance from their physician or their physician team or their cancer center, but they'll have to reach out to other patients, and I'm so glad that that information is being shared. But it seems like we could be doing better. More orderly assistance, more navigation, more direct help to patients who actually need it in the way that they need it because it's not one size fits all.  

Now, switching topics just a little bit, I had the pleasure of working with Dr. Littman, who is a resident at NYU, on a review in this issue about the role of cost conversations to decrease financial toxicity. And I know from my own prior research that only about 5% of oncologists say that they've had any training on discussing costs and that cost conversations seem to be rarely happening in clinical practice. Certainly from my own perspective as a cancer caregiver, I can say that cost conversations, despite incredible financial toxicity from my husband's treatment, were just not being had. Now, Kelly, have you ever had a discussion about cost with your treating team?

Dr. Kelly Shanahan: I have never had my treating team ever bring up costs. Now, as I mentioned before, when at one point I was contemplating going on a CDK4/6 inhibitor, I did say, “If I need to go on a CDK4/6 inhibitor now with this huge co-pay, I'm not going to do it.” But I didn't get that, “Oh, here's some resources that we can have.” I was sort of like, “We'll figure that out. You don't need it right now.” And fortunately, I did not need it until I was able to get on an assistance program and then had Medicare. So it wasn't prohibitively expensive. Although I did fall into that catastrophic donut hole one year. That was not fun. 

But I think this is something that we patients talk about frequently. People, they're worrying about paying their bills, about paying their medical bills, do they pay their hospital bill or their doctor's bill or do they buy food? Do they pay their utility bill or do they pay the co-pay for their medication? And we should not, in the supposedly richest country in the world, be having to have these conversations. We share resources about people who have unused medications. If you have progression of your cancer and you have to switch medications, but you still have two months of a three-month supply, how can that be legally distributed to other patients? And there are organizations that can do that. We try to let people know about that. But yeah, patients frequently talk about this. It's so heartbreaking when someone has to do a GoFundMe to pay for their medical care or to pay for their funeral or the funeral of a loved one. 

Dr. Fumiko Chino: Yeah. My standing joke, which is not really a joke, it's more of a ‘ha-ha sob’, is that GoFundMe is actually the US's largest cancer insurance provider, which is fundamentally very depressing. And I think one of the points that you pointed out about just even just eliminating waste- so if I have a drug that I'm no longer using, how do I donate that to the next needy person? When my husband died from cancer, we had a supply of Zofran that we had paid very dearly for. He was past his pharmaceutical benefit. We were paying $35 a pill. This is when Zofran ondansetron was still on patent. And I was like, these pills are very expensive. And I turned them over, actually, to my mom who's a physician to distribute in her clinic because I wanted people to not have uncontrolled nausea. I know now, working at world leading cancer centers that there's no actual way of doing that here, but a community cancer center can do it. I think we just- trying to get more efficient all across the board is so important. 

Now, Ryan, how do you broach the topic of affordability with your patients? Do you try to preemptively discuss costs or really just wait for when there seems to be a problem with affordability?

Dr. Ryan Nipp: Yeah, I knew this was coming up. I think it's a bit of a touchy topic at times because you don't want to presume and like to bring it up. In some ways, there's this option of, at least in Oklahoma now, where people are traveling a long distance often to see us here in Oklahoma City. And so sometimes you can just start to broach the idea of like how much trouble was it to get here? Do you think you'll be able to make these trips every two weeks? That two hour drive, how's that going to be? But in general, I think I am talking more in recent years about the issue of financial toxicity. I agree with Kelly. It's rare when it does come up, but in recent years it's coming up slightly more often than maybe zero like it used to be. And I think, for one, it's because patients are bringing it up more. I think they're feeling more empowered to talk about it. It's more you're able to have that opening to bring this up to me. I would welcome the opportunity. Of course, I'm passionate about this topic. And then second, I think there's increasing awareness of the available resources. There actually are things that are being studied and there may be options. Whereas in the past, perhaps we were totally just at a loss, like if our patients would bring it up, we would feel awful for them, but there wasn't a lot we could offer. And again, in Oklahoma now, we have phenomenal social work that is available to us at all times, as well as that financial navigation as I was hinting at before. 

But also, Kelly, you mentioned this before and thinking about this, the fact that we have clinical pharmacists in clinic with us that are just sitting right next to us in clinic has been a priceless resource for me. I found their insights and expertise to be very helpful in finding ways to address financial toxicity. Are there other ways that we can help this person? They brought up that this new anticoagulation pill that they're getting is super expensive. What can we do to help them? Things like that. They're with me. They're willing to look into are there other things that we could be doing again? Also at University of Oklahoma, when I got here, actually, they were already doing some work on this idea of financial toxicity screening, meaning: Can we preemptively be asking patients about their financial hardship or financial needs? And then when things are identified, again, we have cancer center navigators who are available to us for those positive screens to help put people on whatever paths we have available to address those things.

Again, in our special series that we have coming out in JCO Oncology Practice, we have a few articles that also talk about this idea of utilizing screening tools and questionnaires to identify patients who may be at risk for financial toxicity. And then some of the work that's growing with regards to once you identify somebody who screened positive, what to do with that positive financial toxicity screen.

Dr. Kelly Shanahan: And you know, you bring up that idea of bias and stigma, and I think that can be easily eliminated by asking every single patient. Doesn't matter whether somebody rides the bus in or they roll up in a Rolls Royce. If we ask every single person: Are you having any financial hardships related to your cancer treatments? Then we normalize it, we remove that stigma, and then we can help more people.

Dr. Fumiko Chino: And I've definitely seen that, I'm sure, from your own practice as an OB/GYN, like STI screening, we ask every single person about STI screening and it's not targeted towards youth. We ask everyone in a cancer center for falls. Have you had a fall? That's just part of our routine screening. So I feel like integrating one or two questions about financial toxicity could be a real avenue for helping identify financial toxicity earlier. Hopefully, intervening before it gets to the point at which it's end stage of financial toxicity, so to speak, when people are not showing up for their appointments anymore at all. 

Now, we're heading towards the final part of our conversation today. I just wanted to give a little bit of space for open topic conversation. Is there anything that you feel like we really just should address for the future of financial toxicity? Whose voices are here, whose aren't? How do we make actual meaningful change to stop describing the problem but actually start to fix the problem? 

Dr. Kelly Shanahan: Well, I certainly think the payers need to be pulled into the mix because they're the ones that are leading to denials. They are the ones that are requiring prior authorization for antiemetics for highly emetogenic chemotherapy. So I think they need to be pulled into the mix. I think our physicians, our care team, need to be pulled into the mix as well as the patients and caregivers.

Dr. Fumiko Chino: Ryan, anyone that you want to have more involved in this conversation, any way to expand it?

Dr. Ryan Nipp: You mentioned it there at the end, Kelly, is the caregiver. I think we haven't done a lot of work looking at that. Again, back to the research part and describing the issue, we haven't really done a lot looking at the caregiver side. The other piece that I think as we were putting together this special series was the international global perspectives that we did have a little bit of trouble trying to find. It's just different across different geographic and global areas so that's something else that should be studied more. We kind of hinted at it today, this idea of pharmacists being involved. We haven't seen a lot of work in that space. The other thing to think about is, at least in the places where I've practiced the APPs or the individuals seeing our patients a lot of the time and also empowering them to bring this up and have some tools and just bringing them into the research realm and to future intervention development. 

The last thing I'll say, because we have brought it up a few times today, but I do think a wide open area is what do we do about clinical trials and the affordability of being on a clinical trial and making that more available or able for patients to be going onto clinical trials. I think that's an interesting space to continue to research. 

Dr. Kelly Shanahan: Yeah. Step number one, every single patient with advanced cancer should be offered a clinical trial. Again, no assumption should be made. And number two, we need to make it so that everyone can afford to, time wise, money wise, to participate in clinical trials. It was a great privilege. I am so grateful that I was able to do a clinical trial and I look forward to doing others in the future.

Dr. Fumiko Chino: Absolutely. I really think that this idea of travel burden is such a huge barrier for many of our patients for getting even standard of care treatments, but much less enrolling on a clinical trial. And every piece of data that I've ever seen shows that you will actually get more enrollment and a more diverse patient population on your clinical trials if you just open the clinical trial closer to where the patients are actually living and getting their cancer treatment. So decentralized trials or trials within community practices, trials within the NCORP or the NCI's Community Cancer Center, or even again within regional centers affiliated with academic medical centers. These are always, I feel like, decreasing that travel burden. 

Dr. Kelly Shanahan: And I just thought of one really simple way to decrease financial burden on patients. Just going for tests, imaging, doctor's visits - a patient should never have to pay for parking.

Dr. Fumiko Chino: Now, you're beating a drum that I can dance to. The parking ridiculousness. It led to, honestly, I think, at this point probably my most read research topic, which was just evaluating parking costs. And it is such a stupid thing to study. The fact that parking could be a barrier to receiving optimal medical care is so frustrating, infuriating if nothing else. And yet it is so common. I saw it in my practice in New York where they just couldn't afford to travel into Manhattan for anything that had to be done on the main center. It's a ridiculous barrier.

Dr. Kelly Shanahan: $5 an hour to park at UCSF to go see your doctor, get imaging, or get labs.

Dr. Fumiko Chino: Absolutely. And the funny thing is that the travel and the parking then must be balanced with the time toxicity, which is consolidating all appointments down could at least decrease your parking costs. But then you're literally at the cancer center the entire day and then you need to buy your lunch at the cancer center or you missed out on another day of work potentially. And so really thinking about this from a very patient centered framework is so essential to just move forward. And it's one of the reasons why I've been so honored and privileged to collaborate with patient advocates like Dr. Shanahan. 

Well, I will wrap it up. I want to thank you so much for having such a robust conversation today about such an important topic. I can't really think of a better focus for our first podcast issue. I really want to thank both of our guests and also our listeners for your time today. You can find links to the papers that we discussed in the transcript of this episode. And if you value the insights you hear on the JCO OP: Put into Practice podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. As a new podcast, we really do depend on you, the listeners, to spread the word that we're out there and we'll hope that you join us next month for our second episode. Until then, please stay safe and warm in 2025.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Disclosures:

Kelly Shanahan:Consulting or Advisory Role: Pfizer, SeaGen, Sermonix Pharmaceuticals, Jaguar Health/Napo pharmaceuticals

Dr. Pennell and Dr. James Hammock discuss the provision of oncologic services by Project Access safety net care coordination programs.

NATHAN PENNELL: Hello, and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org.

My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consulting editor for the JCO OP. I have no conflicts of interest related to this podcast. And a complete list of disclosures is available at the end of the podcast.

Today, I'd like to talk a little bit about the complexities of providing cancer care for patients who are uninsured or underinsured, which is a relatively large percentage of patients in the US.

How do patients without insurance receive cancer care? One way is through community programs, including a program called Project Access, a care coordination program connecting patients to specialty medical care at no or reduced cost, including, in some instances, oncology care.

But how does it work? Who does it help? And how impactful are this and other programs designed to obtain cancer care for low-income, uninsured, and underserved patients? With me today to discuss this topic is Dr. Jamey Hammock, a resident in internal medicine at the University of Alabama Birmingham.

We'll be discussing the paper from he and his colleagues titled, Oncologic Services Through Project Access and Other Safety Net Care Coordination Programs, which was published online July 31, 2020 in the JCO OP. Welcome, Jamey, and thank you for joining me on the podcast.

JAMEY HAMMOCK: Hey. Thank you, very excited to be here. I did want to say too that I do not have any conflicts of interest or disclosures for this particular study.

NATHAN PENNELL: Why don't we start out by talking a little bit about how big a problem it is for providing cancer care in uninsured and underinsured patients in the US.

JAMEY HAMMOCK: It's an enormous problem. If you look at previous studies, they've looked at patients who are underserved, underinsured, or even uninsured with cancer. And these patients actually typically present with later stage disease, they experience delays in treatment, and ultimately have worse overall survival compared to well-insured patients.

So just that alone tells you how big of a problem that this is. I think that when you look at cancer care for underinsured and uninsured, you have to break those things up. And you can't really talk about it without talking about the Affordable Care Act.

So let's take uninsured patients, for example. If you look at pre-Affordable Care Act and post-Affordable Care Act, there's a great study in 2017 that really broke down these two groups, pre and post. And what they found is with the Affordable Care Act, if you are uninsured across any income level and you lived in a Medicaid expansion state, the percentage of patients who were uninsured decreased from about 5% to 2 and 1/2%. So it really cut that percentage in half, which is pretty impressive.

And then if you look at low-income uninsured patients, because they broke that down in the study, the percentage actually dropped from around 10% to 3 and 1/2%. So It just shows you when you talk about absolute numbers and then those percentages, how many individuals are really affected that have a diagnosis of cancer and are uninsured. And it gives you a little bit of insight of what Medicaid expansion has done for that group.

And then I want to touch really quickly too on underinsured. So basically underinsured patients, they don't have the means to get the care that they need, even if they have insurance. That's important.

And patients with Medicaid, for example, they have insurance, but they have their own challenges. For example, there's been studies showing that they have longer wait times to see some specialists. It's harder to find a physician that takes patients with Medicaid.

Lastly, these providers are so few and far between that sometimes these patients are asked to drive very long distances to get the care they need. And you're already talking about a disadvantaged patient population who may not have the means to drive an hour away to get to their visit.

NATHAN PENNELL: That sounds very challenging situation, even for people who technically have health insurance, and still don't necessarily have what they need to access care the way it should be given.

Can you tell us a little bit about Project Access? I have to admit, I had never heard of that before I read this paper. And it was a fascinating program that something like this exists. Can you tell us a little bit about it?

JAMEY HAMMOCK: Absolutely. So Project Access, first off, they do great work. It's a nonprofit organization that really, really works hard to try to get patients who are underinsured and uninsured subspecialty care.

So I want to talk real briefly about the history first because I think it helps you understand why Project Access came to be. I think we need primary care pretty well in the US for patients who are underinsured and uninsured. We have things called community health centers, which are federal qualified health centers funded by the government.

And they really do a good job providing primary care for patients who cannot get it elsewhere. The problem is that a lot of these patients ultimately will end up meaning a subspecialist. And there does not exist a community health center for subspecialty care that's funded by the government the way that community health centers are.

One thing to address this was Medicaid expansion. Medicaid expansion was supposed to increase the amount of patients who got insurance and thus wouldn't be able to obtain the subspecialty care that they need.

But we've already talked about some of the shortcomings of Medicaid expansion, including not all states have done that, decided to expand unfortunately. And if you're an undocumented immigrant, unfortunately, you don't have access many times to government programs.

So it doesn't do anything for those populations. There's been some other strategies, Dr. Pennell, to try to address subspecialty care in these populations, things like telehealth, and which you would need the technology, things like subspecialists actually coming to community health centers, let's say, every other Friday to see a patient who needs a cardiologist or an oncologist.

But the problem with that is it's a little sporadic, it's inconsistent. And sometimes these patients can't be that flexible and come in the only day that the specialist is going to be there. And so really, here enters Project Access to say, you know what, let us negotiate-- pre-negotiate with subspecialists in the community that surround these community health centers and find subspecialists that agree to see x amount of patients a year.

And when it comes time to refer a patient to a specialist, you contact us, and the work has been done. And so they sort of broker, if you will, or negotiate between some specialists in primary care. And they do a lot of the groundwork that it takes to get these patients the subspecialty care they need to get the results of the subspecialty visit back to the primary care. They do all of that legwork. And so they really are an incredible, incredible service.

I do want to mention, they're more of a local solution. So Project Access Birmingham, for example, it serves the residents of Jefferson County. It's not meant to be a statewide solution. They're very good at serving the patients who are near, who are in the county.

And in fact, a lot of them have requirements that you be a resident of the county that they operate in. But they do a wonderful job getting these patients the subspecialty care that they need.

NATHAN PENNELL: Well, I have more questions about Project Access. But I think you're going to answer some of them when we start to talk about your paper. So why don't you just start off by talking us a little bit about, what was the purpose of the project that you did and how did you design your quality project.

JAMEY HAMMOCK: This project started out as a genuine question I had working as an intern in internal medicine. I would see patients come into our hospital who were uninsured who had a malignancy or cancer. And I would just ask, where do these patients get their care. How are they suppose to get outpatient clinic follow-up?

So that's when I learned about Project Access locally here in Birmingham. And as you just mentioned, I had a ton of questions. So I actually went and met with Project Access and just asked them all of these questions.

How do you work? How is your funding? Who do you see? What specialties do you provide, et cetera, et cetera.

And I decided I wanted to really take an in-depth study and look at our Project Access here in Birmingham. When I began doing the literature review for that, I realized that there was not much out there in terms of this Project Access model. I was told that many other ones exist across the country, but there had not been a lot done in the medical literature describing these places and the wonderful work that they do. And so at that point, I began to zoom out a little bit and look at all of the Project Access centers that exist in the country.

NATHAN PENNELL: What did you find out when you started calling and checking in with all of the different Project Access programs?

JAMEY HAMMOCK: To kind of bring things back to home, I really was particularly interested in how these Project Access centers offer oncology care because oncology care is a little bit different than other subspecialties in terms of the resources needed to provide such care. And my interest was, how do programs who are nonprofit who are trying to work with underinsured/uninsured patients provide care that require so much resources. So that was really one of my objectives is to tailor my approach to oncology care, specifically, while also describing the programs in general.

And so what I found was that out of about 30 programs that I found, roughly 2/3 offered care medical oncologists. And then out of those 2/3, about 1/2 of those programs actually offered chemotherapy.

Fortunately, everyone offered radiographic studies, such as MRI, CT, PET scan. So they could at least assist in diagnosing or helping to diagnose suspicion for a malignancy. Obviously, that doesn't include a biopsy, but could at least sort get the ball rolling, if you will.

And then the other thing I discovered is, as I mentioned previously in the podcast, there was a lot of heterogeneity between the programs. So some programs offer transportation, some programs offered interpreter services, while others did not. Some programs required small co-pays. It seemed that everything was really tailored to their respective local community and what worked best for that community.

In terms of Medicaid expansion, which was sort of another thing we were looking at with this study, what we found is about 2/3 of the states that have not expanded Medicaid have a Project Access center. And if you compare that to states that have expanded, only about one third of those have Project Access centers.

And so our study suggests that the need for pro bono care is a little higher in Medicaid non-expansion states. And I think that that's intuitive. The percentage of uninsured patients with cancer in a non-expansion state is as high as 13%, depending on what their income is. And that's compared to about 2% to 3% in a state that's expanded Medicaid. So those are drastically different numbers and drastically different needs for patients, depending on if they reside in a state that has expanded Medicaid.

NATHAN PENNELL: But it seems as though the difference between areas that had programs that offered cancer care and those that didn't probably revolve around whether they're able to find practitioners who are willing to provide those services. And it looks like you did some investigating of programs that did and did not offer cancer care. So what were the differences between those?

JAMEY HAMMOCK: The next step of my project was to interview those program coordinators of the centers who were not able to offer medical oncology care. And three common themes emerged as I talked to these program directors.

The first of those themes was cost. And I think that that's intuitive. And it did not surprise me. Medical care is expensive. Oncology care is expensive. And these programs, they're mostly nonprofit and rely on donations and such.

And so the first barrier to offering this is cost. The patient see the medical oncologist, and they prescribe chemotherapy, someone has to pay for that chemotherapy.

And a lot of Project Access centers were not prepared to do that. One in particular I spoke with, they had actually considered it. And when they ran the numbers, it would account for over half of their annual budget. So it just was not feasible.

The second barrier that emerged while I was talking to these program directors was the concept of continuity and a longitudinal commitment. So for example, if I'm a medical oncologist and I decide that I want to take part in this and donate some of my services, and I see a patient that has a new diagnosis of cancer, and we treat the cancer, what happens if they relapse or what happens in five years that they need a medical oncologist again?

And I don't think many oncologists were comfortable committing to a situation that had no clear end date. That's in contrast to a patient that has COPD and the primary care physician is referring them to a pulmonologist to get recommendations on maintenance inhalers and what might work best for this patient. That's more of a one and done visit.

The third area barrier emerged as I talked to these patients was the concept of multiple physician buy-in. And so, as you're aware, many patients that have a cancer may require care from multiple subspecialties, whether that be surgical oncology, medical oncology, radiology, diagnostic radiology, and even palliative care. And so it really is a disservice to a patient if you can offer them not the full scope of oncological care that they need. A lot of Project Access centers were not comfortable providing some of the care without providing all of the care, if that makes sense.

NATHAN PENNELL: I mean, all of those make perfect sense. I mean, although in some ways they relate partly back to the first issue, which is that things cost more if they take a long time and have to continue indefinitely over time.

So I'm curious, for the places that did offer chemotherapy, and actually even though it was a relatively small percentage, it was not trivial, chemotherapy is extremely expensive. As you mentioned, some of them looked at it and decided it was going to be something like half of their revenue for the year would be taken and providing this. How did those that covered chemo actually cover the cost of that?

JAMEY HAMMOCK: That's a great question. I had the same question. And so what we found is that most of the programs who were able to offer medical oncology and then services, and then taking the next step to offer chemotherapy, they were affiliated with very large hospital systems in the area.

So I'll give you an example. Here in Birmingham, our Project Access center works with UAB. And they're able to offer these services because UAB takes the baton, if you will, and carries the care forward, offers that chemotherapy that is needed. So it's done through large affiliated hospital systems. If that does not exist, or if that relationship is not there, then what my study has shown is that it's not feasible.

NATHAN PENNELL: Right. That makes sense. I mean, individual oncology offices that order their own chemotherapy could probably never afford to just donate that, whereas large systems have other ways to do that. And of course, the large nonprofits also have to give back to the community and may just consider that part of their community service.

What's the next step to extend this? I guess, the larger question is, it'd be great if perhaps everyone had health insurance. But until that happens, what steps can be taken to provide something like this more broadly?

JAMEY HAMMOCK: Yeah, so that is exactly what I was thinking. Medicare for all is the answer. And ultimately I think we need a centralized universal health insurance policy. But that's not the topic of this podcast.

So until then, Project Access is stepping into the gap and doing this great work. And I really wanted them to be recognized just as a organization, broadly speaking, and then on an individual basis. They are on the ground doing the hard work, making the phone calls, making the partnerships, raising the money. They're really doing incredible, incredible work for people out there who have no other options.

It's not enough. As I mentioned earlier, these are local solutions to statewide issues. If you look at Alabama, it's a non-expansion state, unfortunately. The patients in Jefferson County here where Birmingham is, they benefit from Public Access, but the patients in Shelby County might not. So it's a statewide issue for the states that don't have Medicaid expansion, and then even a small population in the states that do.

One thing that we can do is we can look at the examples that have been set by Project Access centers who have partnered with these hospitals and collaborate and say, listen, we're a Project Access center that has not had any luck. Please share with us how you were successful in providing oncology care to your patients.

My hope is that this project provides a list where collaboration can begin. And these places can learn from each other.

NATHAN PENNELL: Well, I think that this is fantastic. And I'm really happy that we're going to be able to highlight Project Access and your manuscript so more people are aware of this and hopefully can start shining lights on their own local Project Access programs.

JAMEY HAMMOCK: Right, right.

NATHAN PENNELL: Well, Jamey, thank you so much for joining me on the podcast today.

JAMEY HAMMOCK: Thank you for having me. I thoroughly enjoyed it and love talking about Project Access and access to care. And I really appreciate it.

NATHAN PENNELL: Until next time, I also want to thank our listeners for checking in on this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts, or wherever you listen.

While you're there, be sure to subscribe so you never missed an episode. JCO OP podcasts are just one of ASCO's many podcasts programs. You can find all recordings at podcast.asco.org.

The full text of this paper is available online at ascohubs.org/journal/op. This is Dr. Nate Pennell for the JCO Oncology Practice signing off.

PRESENTER: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care. And is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions.

The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. For more original research, editorials, and review articles, please visit us online at jco.org.

This production is copyrighted to the American Society of Clinical Oncology. Thank you for listening.

Dr. Pennell and Dr. James Hammock discuss the provision of oncologic services by Project Access safety net care coordination programs.

NATHAN PENNELL: Hello, and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org.

My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consulting editor for the JCO OP. I have no conflicts of interest related to this podcast. And a complete list of disclosures is available at the end of the podcast.

Today, I'd like to talk a little bit about the complexities of providing cancer care for patients who are uninsured or underinsured, which is a relatively large percentage of patients in the US.

How do patients without insurance receive cancer care? One way is through community programs, including a program called Project Access, a care coordination program connecting patients to specialty medical care at no or reduced cost, including, in some instances, oncology care.

But how does it work? Who does it help? And how impactful are this and other programs designed to obtain cancer care for low-income, uninsured, and underserved patients? With me today to discuss this topic is Dr. Jamey Hammock, a resident in internal medicine at the University of Alabama Birmingham.

We'll be discussing the paper from he and his colleagues titled, Oncologic Services Through Project Access and Other Safety Net Care Coordination Programs, which was published online July 31, 2020 in the JCO OP. Welcome, Jamey, and thank you for joining me on the podcast.

JAMEY HAMMOCK: Hey. Thank you, very excited to be here. I did want to say too that I do not have any conflicts of interest or disclosures for this particular study.

NATHAN PENNELL: Why don't we start out by talking a little bit about how big a problem it is for providing cancer care in uninsured and underinsured patients in the US.

JAMEY HAMMOCK: It's an enormous problem. If you look at previous studies, they've looked at patients who are underserved, underinsured, or even uninsured with cancer. And these patients actually typically present with later stage disease, they experience delays in treatment, and ultimately have worse overall survival compared to well-insured patients.

So just that alone tells you how big of a problem that this is. I think that when you look at cancer care for underinsured and uninsured, you have to break those things up. And you can't really talk about it without talking about the Affordable Care Act.

So let's take uninsured patients, for example. If you look at pre-Affordable Care Act and post-Affordable Care Act, there's a great study in 2017 that really broke down these two groups, pre and post. And what they found is with the Affordable Care Act, if you are uninsured across any income level and you lived in a Medicaid expansion state, the percentage of patients who were uninsured decreased from about 5% to 2 and 1/2%. So it really cut that percentage in half, which is pretty impressive.

And then if you look at low-income uninsured patients, because they broke that down in the study, the percentage actually dropped from around 10% to 3 and 1/2%. So It just shows you when you talk about absolute numbers and then those percentages, how many individuals are really affected that have a diagnosis of cancer and are uninsured. And it gives you a little bit of insight of what Medicaid expansion has done for that group.

And then I want to touch really quickly too on underinsured. So basically underinsured patients, they don't have the means to get the care that they need, even if they have insurance. That's important.

And patients with Medicaid, for example, they have insurance, but they have their own challenges. For example, there's been studies showing that they have longer wait times to see some specialists. It's harder to find a physician that takes patients with Medicaid.

Lastly, these providers are so few and far between that sometimes these patients are asked to drive very long distances to get the care they need. And you're already talking about a disadvantaged patient population who may not have the means to drive an hour away to get to their visit.

NATHAN PENNELL: That sounds very challenging situation, even for people who technically have health insurance, and still don't necessarily have what they need to access care the way it should be given.

Can you tell us a little bit about Project Access? I have to admit, I had never heard of that before I read this paper. And it was a fascinating program that something like this exists. Can you tell us a little bit about it?

JAMEY HAMMOCK: Absolutely. So Project Access, first off, they do great work. It's a nonprofit organization that really, really works hard to try to get patients who are underinsured and uninsured subspecialty care.

So I want to talk real briefly about the history first because I think it helps you understand why Project Access came to be. I think we need primary care pretty well in the US for patients who are underinsured and uninsured. We have things called community health centers, which are federal qualified health centers funded by the government.

And they really do a good job providing primary care for patients who cannot get it elsewhere. The problem is that a lot of these patients ultimately will end up meaning a subspecialist. And there does not exist a community health center for subspecialty care that's funded by the government the way that community health centers are.

One thing to address this was Medicaid expansion. Medicaid expansion was supposed to increase the amount of patients who got insurance and thus wouldn't be able to obtain the subspecialty care that they need.

But we've already talked about some of the shortcomings of Medicaid expansion, including not all states have done that, decided to expand unfortunately. And if you're an undocumented immigrant, unfortunately, you don't have access many times to government programs.

So it doesn't do anything for those populations. There's been some other strategies, Dr. Pennell, to try to address subspecialty care in these populations, things like telehealth, and which you would need the technology, things like subspecialists actually coming to community health centers, let's say, every other Friday to see a patient who needs a cardiologist or an oncologist.

But the problem with that is it's a little sporadic, it's inconsistent. And sometimes these patients can't be that flexible and come in the only day that the specialist is going to be there. And so really, here enters Project Access to say, you know what, let us negotiate-- pre-negotiate with subspecialists in the community that surround these community health centers and find subspecialists that agree to see x amount of patients a year.

And when it comes time to refer a patient to a specialist, you contact us, and the work has been done. And so they sort of broker, if you will, or negotiate between some specialists in primary care. And they do a lot of the groundwork that it takes to get these patients the subspecialty care they need to get the results of the subspecialty visit back to the primary care. They do all of that legwork. And so they really are an incredible, incredible service.

I do want to mention, they're more of a local solution. So Project Access Birmingham, for example, it serves the residents of Jefferson County. It's not meant to be a statewide solution. They're very good at serving the patients who are near, who are in the county.

And in fact, a lot of them have requirements that you be a resident of the county that they operate in. But they do a wonderful job getting these patients the subspecialty care that they need.

NATHAN PENNELL: Well, I have more questions about Project Access. But I think you're going to answer some of them when we start to talk about your paper. So why don't you just start off by talking us a little bit about, what was the purpose of the project that you did and how did you design your quality project.

JAMEY HAMMOCK: This project started out as a genuine question I had working as an intern in internal medicine. I would see patients come into our hospital who were uninsured who had a malignancy or cancer. And I would just ask, where do these patients get their care. How are they suppose to get outpatient clinic follow-up?

So that's when I learned about Project Access locally here in Birmingham. And as you just mentioned, I had a ton of questions. So I actually went and met with Project Access and just asked them all of these questions.

How do you work? How is your funding? Who do you see? What specialties do you provide, et cetera, et cetera.

And I decided I wanted to really take an in-depth study and look at our Project Access here in Birmingham. When I began doing the literature review for that, I realized that there was not much out there in terms of this Project Access model. I was told that many other ones exist across the country, but there had not been a lot done in the medical literature describing these places and the wonderful work that they do. And so at that point, I began to zoom out a little bit and look at all of the Project Access centers that exist in the country.

NATHAN PENNELL: What did you find out when you started calling and checking in with all of the different Project Access programs?

JAMEY HAMMOCK: To kind of bring things back to home, I really was particularly interested in how these Project Access centers offer oncology care because oncology care is a little bit different than other subspecialties in terms of the resources needed to provide such care. And my interest was, how do programs who are nonprofit who are trying to work with underinsured/uninsured patients provide care that require so much resources. So that was really one of my objectives is to tailor my approach to oncology care, specifically, while also describing the programs in general.

And so what I found was that out of about 30 programs that I found, roughly 2/3 offered care medical oncologists. And then out of those 2/3, about 1/2 of those programs actually offered chemotherapy.

Fortunately, everyone offered radiographic studies, such as MRI, CT, PET scan. So they could at least assist in diagnosing or helping to diagnose suspicion for a malignancy. Obviously, that doesn't include a biopsy, but could at least sort get the ball rolling, if you will.

And then the other thing I discovered is, as I mentioned previously in the podcast, there was a lot of heterogeneity between the programs. So some programs offer transportation, some programs offered interpreter services, while others did not. Some programs required small co-pays. It seemed that everything was really tailored to their respective local community and what worked best for that community.

In terms of Medicaid expansion, which was sort of another thing we were looking at with this study, what we found is about 2/3 of the states that have not expanded Medicaid have a Project Access center. And if you compare that to states that have expanded, only about one third of those have Project Access centers.

And so our study suggests that the need for pro bono care is a little higher in Medicaid non-expansion states. And I think that that's intuitive. The percentage of uninsured patients with cancer in a non-expansion state is as high as 13%, depending on what their income is. And that's compared to about 2% to 3% in a state that's expanded Medicaid. So those are drastically different numbers and drastically different needs for patients, depending on if they reside in a state that has expanded Medicaid.

NATHAN PENNELL: But it seems as though the difference between areas that had programs that offered cancer care and those that didn't probably revolve around whether they're able to find practitioners who are willing to provide those services. And it looks like you did some investigating of programs that did and did not offer cancer care. So what were the differences between those?

JAMEY HAMMOCK: The next step of my project was to interview those program coordinators of the centers who were not able to offer medical oncology care. And three common themes emerged as I talked to these program directors.

The first of those themes was cost. And I think that that's intuitive. And it did not surprise me. Medical care is expensive. Oncology care is expensive. And these programs, they're mostly nonprofit and rely on donations and such.

And so the first barrier to offering this is cost. The patient see the medical oncologist, and they prescribe chemotherapy, someone has to pay for that chemotherapy.

And a lot of Project Access centers were not prepared to do that. One in particular I spoke with, they had actually considered it. And when they ran the numbers, it would account for over half of their annual budget. So it just was not feasible.

The second barrier that emerged while I was talking to these program directors was the concept of continuity and a longitudinal commitment. So for example, if I'm a medical oncologist and I decide that I want to take part in this and donate some of my services, and I see a patient that has a new diagnosis of cancer, and we treat the cancer, what happens if they relapse or what happens in five years that they need a medical oncologist again?

And I don't think many oncologists were comfortable committing to a situation that had no clear end date. That's in contrast to a patient that has COPD and the primary care physician is referring them to a pulmonologist to get recommendations on maintenance inhalers and what might work best for this patient. That's more of a one and done visit.

The third area barrier emerged as I talked to these patients was the concept of multiple physician buy-in. And so, as you're aware, many patients that have a cancer may require care from multiple subspecialties, whether that be surgical oncology, medical oncology, radiology, diagnostic radiology, and even palliative care. And so it really is a disservice to a patient if you can offer them not the full scope of oncological care that they need. A lot of Project Access centers were not comfortable providing some of the care without providing all of the care, if that makes sense.

NATHAN PENNELL: I mean, all of those make perfect sense. I mean, although in some ways they relate partly back to the first issue, which is that things cost more if they take a long time and have to continue indefinitely over time.

So I'm curious, for the places that did offer chemotherapy, and actually even though it was a relatively small percentage, it was not trivial, chemotherapy is extremely expensive. As you mentioned, some of them looked at it and decided it was going to be something like half of their revenue for the year would be taken and providing this. How did those that covered chemo actually cover the cost of that?

JAMEY HAMMOCK: That's a great question. I had the same question. And so what we found is that most of the programs who were able to offer medical oncology and then services, and then taking the next step to offer chemotherapy, they were affiliated with very large hospital systems in the area.

So I'll give you an example. Here in Birmingham, our Project Access center works with UAB. And they're able to offer these services because UAB takes the baton, if you will, and carries the care forward, offers that chemotherapy that is needed. So it's done through large affiliated hospital systems. If that does not exist, or if that relationship is not there, then what my study has shown is that it's not feasible.

NATHAN PENNELL: Right. That makes sense. I mean, individual oncology offices that order their own chemotherapy could probably never afford to just donate that, whereas large systems have other ways to do that. And of course, the large nonprofits also have to give back to the community and may just consider that part of their community service.

What's the next step to extend this? I guess, the larger question is, it'd be great if perhaps everyone had health insurance. But until that happens, what steps can be taken to provide something like this more broadly?

JAMEY HAMMOCK: Yeah, so that is exactly what I was thinking. Medicare for all is the answer. And ultimately I think we need a centralized universal health insurance policy. But that's not the topic of this podcast.

So until then, Project Access is stepping into the gap and doing this great work. And I really wanted them to be recognized just as a organization, broadly speaking, and then on an individual basis. They are on the ground doing the hard work, making the phone calls, making the partnerships, raising the money. They're really doing incredible, incredible work for people out there who have no other options.

It's not enough. As I mentioned earlier, these are local solutions to statewide issues. If you look at Alabama, it's a non-expansion state, unfortunately. The patients in Jefferson County here where Birmingham is, they benefit from Public Access, but the patients in Shelby County might not. So it's a statewide issue for the states that don't have Medicaid expansion, and then even a small population in the states that do.

One thing that we can do is we can look at the examples that have been set by Project Access centers who have partnered with these hospitals and collaborate and say, listen, we're a Project Access center that has not had any luck. Please share with us how you were successful in providing oncology care to your patients.

My hope is that this project provides a list where collaboration can begin. And these places can learn from each other.

NATHAN PENNELL: Well, I think that this is fantastic. And I'm really happy that we're going to be able to highlight Project Access and your manuscript so more people are aware of this and hopefully can start shining lights on their own local Project Access programs.

JAMEY HAMMOCK: Right, right.

NATHAN PENNELL: Well, Jamey, thank you so much for joining me on the podcast today.

JAMEY HAMMOCK: Thank you for having me. I thoroughly enjoyed it and love talking about Project Access and access to care. And I really appreciate it.

NATHAN PENNELL: Until next time, I also want to thank our listeners for checking in on this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts, or wherever you listen.

While you're there, be sure to subscribe so you never missed an episode. JCO OP podcasts are just one of ASCO's many podcasts programs. You can find all recordings at podcast.asco.org.

The full text of this paper is available online at ascohubs.org/journal/op. This is Dr. Nate Pennell for the JCO Oncology Practice signing off.

PRESENTER: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care. And is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions.

The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. For more original research, editorials, and review articles, please visit us online at jco.org.

This production is copyrighted to the American Society of Clinical Oncology. Thank you for listening.

Dr. Pennell and Dr. Friedman discuss the variety of ethical dilemmas for health care providers brought on by COVID-19.

NATE PENNELL: Hello, and welcome to the latest JCO Oncology Practice Podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org

My name is Dr. Nate Pennell, Medical Oncologist at the Cleveland Clinic, and consultant editor for the JCOOP. I have no conflicts of interest related to this podcast, and a complete list of disclosures is available at the end of the podcast. Today I want to talk about a very serious topic that all of us who care for cancer patients really had at the front of our minds back in the spring of 2020. While it may already seem like a long time ago, when the COVID pandemic was at its peak in the United States, New York City was being inundated with of COVID. And for a while there was quite a bit of uncertainty about whether they might run out of personal protective equipment or ventilators. And there were very serious discussions happening about allocation of resources.

I personally remember patients asking me, even here in Ohio, if they might not be offered a ventilator if they became sick, because of their cancer diagnosis. And while this certainly never came close to happening in Ohio, I think it actually came closer than we'd like to admit in places like New York. With me today to discuss this really fascinating topic is Liz Blackler, who is the program manager for the Ethics Committee and Consult Service at Memorial Sloan Kettering Cancer Center in New York City.

We'll be discussing the upcoming manuscript from her and her colleagues titles, "COVID-19-related Ethics Consultations at a Cancer Center in New York City-- a Content Review of Ethics Consultations During the Early Stages of the Pandemic," which was published online August 27, 2020 in the JCOOP. Welcome Liz, and thank you for joining me on the podcast.

LIZ BLACKLER: Thank you so much for having me here today. I'm definitely looking forward to discussing our manuscripts with you. Just to note, I do not have any relationships or disclosures related to this study.

NATE PENNELL: Thank you. So what was it like to be really in the epicenter of the COVID pandemic back in the spring?

LIZ BLACKLER: There was a lot of uncertainty. We were all just trying to find our way, to figure it all out. Staff was just reconciling what was happening in real time in the city and the world, and then looking into our own hallways, seeing what was happening there. I would say it was both chaotic and eerily quiet. Our ethics consultation service, as with many ethics consultation services in the hospital, went virtual. So only those people who needed to be on site were there. And the rest of us were working from home.

And so I think as a staff, we were adjusting to doing our jobs remotely, and also watching and feeling the enormity of what was happening at the hospital with patients, and feeling just a little bit far away.

NATE PENNELL: So you are in charge of the ethics consult service. I think anyone who's ever been involved in a case that needs to involve the ethics consult service knows how incredibly interesting a job that must be, and complicated. Can you just, before we get into the COVID thing, explain what an inpatient ethics consult team does, and who is on that team?

LIZ BLACKLER: Sure. So ethics consultations are most frequently requested to help analyze and resolve complex value-laden concerns that arise between or among clinicians, and patients, and/or families. Anyone-- clinicians, non-clinician staff, patients, family members, health care agents, surrogate decision makers can request an ethics consultation. And depending on the situation, the consultant may facilitate communication between the stakeholders. This also involves clarifying treatment options and prognosis.

Our consultants also help opine moral reasoning and ethical principles to certain situations. And we spend quite a bit of time confirming and clarifying state and federal laws, and hospital policy, and how it relates to the specific patient at hand. In general, the ethics consultants work closely with all parties to help identify acceptable courses of action. Our clinical ethics consultation team is a standing subgroup of the ethics committee. And the group is voluntary, and is comprised of 10 MSK employees from a variety of disciplines. These consultants are additionally trained in clinical ethics. And currently we have nurses and physician assistants, nurse practitioners, social workers, and physicians representing psychiatry and critical care medicine.

So we work in a single-modeled service, meaning consultants work independently, and then reach out to other consultants for assistance as needed. So we are a busy service at baseline. And during COVID, our ethics consultations actually doubled.

NATE PENNELL: Yeah, I can see that when you start to delve into your paper, and the issues that came up. And what are the special ethical concerns that arose that might involve COVID in patients with cancer that differed from the usual things you would see patients about in the hospital?

LIZ BLACKLER: Sure, it was actually what spurred us to do a retrospective review on our ethics consultation service. We encountered two, I would think, unique issues that came up that we had not previously seen before on the ethics consultation service. Our very first COVID-19-related ethics consult focused on a patient with decisional capacity who was admitted to the floor, and wanted to be discharged against medical advice while he was waiting for his COVID-19 test to come back.

In the beginning, it was taking a couple of days to get those results back. Staff was very concerned if a patient would not adequately quarantine at home, while we are waiting for the results. In fact, he said he would not quarantine, that he would be out in the subway, and this and that. So we were called in to assist in clarifying whether respecting this patient's autonomy to leave the hospital AMA outweighed our obligation to keep the patient in isolation, and prevent him from potentially spreading the infection.

We had never encountered an issue like that before. So in that case, we were able to support the patient, and help him understand the reasoning why he needed to stay. In the early days of the pandemic, as we were just sorting out what was causing the spread of COVID, I think we would have likely leaned towards figuring out a way to keep him, as long as we could. It's always tricky in that we don't want to override someone's autonomy, unless absolutely necessary. And so there were two cases like this, where we really had to weigh the risk to the public against individual autonomy of the patient.

NATE PENNELL: Yeah, I know. It's very interesting to think about something like that. At first blush, it seems as though there would be no legal way to keep someone if they wanted to leave. But then switch it out and say, well this patient has Ebola now, and wants to go out on their own. And suddenly it jumps to the front of your mind that maybe it's not quite so simple. It also, I think, illustrates nicely what the ethics team does, which is not necessarily to come in and deliver an academic treatise on the ethical principles of who's right and who's wrong, but to help negotiate the different parties to come to an acceptable agreement.

LIZ BLACKLER: Exactly. And in a similar case, we had a family who was wanting to leave the hospital, and go to a local hotel. But at the time, the hotels were either COVID-positive hotels or COVID-negative hotels. And this family insisted on having their loved ones stay at the hotel that was a COVID negative hotel. And so the staff called a similar consult line to know whether they had an obligation to share the patient's medical status with the hotel. And in a similar mind, we did just what you said. We pulled the whole team together. We met with the patient and family, expressed our concerns, and actually helped identify an acceptable hotel that would make a concession, that was in the geographic location of where they wanted to be, that would in fact sterilize and come up with its own private entrance for this patient. So everybody was happy, right? We knew he would be safe, and the family got to have this loved one closer to home.

NATE PENNELL: I'm sure that doesn't always end up with such a good result at the end. But that sounds like a good job. So you had some fascinating consults. So most of your manuscript is describing some of the examples of the types of scenarios that you had to address. So can you take us through some of those, both just like the general themes and then maybe some specific examples?

LIZ BLACKLER: Of course. So like I said, we performed a retrospective review of all of our COVID-19 ethics-related consults that happened between mid-March and the end of April. There were 26 consults total performed on 24 unique patients. The most common ethical issue was related to code status. So these were patients. Staff members were concerned about incubating, or performing cardiopulmonary resuscitation, because of the high risk for aerosolizing procedures.

If you remember, at the beginning of the pandemic, there was a high level of anxiety about supply shortage of personal protective equipment. So staff was very concerned about whether it was ethically appropriate to provide CPR for our patients with poor prognosis, because many, if not most of our patients at that time, not only had advanced cancer, but they had concurrent COVID-19 infection. They had a poor prognosis. Because there was a lot of risks to providing the CPR and intubation with minimal benefit, and so more than half of our consults came through that were questioning that, this idea of non-beneficial treatment.

NATE PENNELL: Well, I guess it's hard not to stop, and talk about that a little bit. So you've got a patient with advanced cancer, who presumably wants to be full code, but is COVID positive. How do you even start to address something like that with the patient and the staff who are worried?

LIZ BLACKLER: As you know, many of our patients with advanced cancer and respiratory distress, it's quite hard to have conversations with them for lots of reasons. I think complicating the situation was we had a zero visitor policy at that time at the hospital. So all hospitals in the state had zero visitor policies. There was no family or caregivers or agents at bedside. We had family at home listening to the news, and they're recognizing how important something like a ventilator was for patients with COVID, as a bridge to recovery. And many family members very much wanted to give their loved one an opportunity to recover from COVID, despite something like a stage 4 lung cancer diagnosis with no [INAUDIBLE]

And so as you can imagine, on a day-to-day basis pre-COVID, we do a lot of goals of care discussion. So we spend a lot of time with patients and families trying to help them understand the limitations to treatment at the end of life, and what is ethically and morally appropriate, and what may not be the right thing to do. And so we had to apply all of those same tactics in a very expedited fashion, talking with family who were isolated and removed from the situation, who could not be at bedside with their loved one to try to help them come to terms with what was happening.

What you may not know is New York state has a law that says full code, cardiopulmonary resuscitation is the de facto intervention for all patients, unless they consent specifically to a do-not-resuscitate order. So we were obligated by law to perform cardiopulmonary resuscitation on all patients with families who wanted it. And so we spent a lot of time talking with our families to help them understand what's happening. And some of those patients did have cardiopulmonary resuscitation, and others understood the gravity of the situation, and were more amenable to do-not-resuscitate orders.

NATE PENNELL: Yeah, it must have been incredibly challenging. But any other themes that arose in terms of the consults that you received?

LIZ BLACKLER: Interestingly we had three or four consults that came through by staff that were concerned that patients were requesting a do-not-resuscitate order prematurely, that it was not standard of care for their clinical situation. What we suspected that it was the converse of what was happening. Patients and families had this altruistic response to the local and national focus on scarce resources. So saying, wow, we understand how difficult things are right now. We're OK. Please focus your resources on someone else.

NATE PENNELL: Wow.

LIZ BLACKLER: So that was--

NATE PENNELL: Yeah, I can imagine that would have been-- well hopefully, I guess, that might not have been quite as challenging. Because maybe some of that might have been a lack of understanding about the prognosis, and people who actually did have a reasonable prognosis might-- I don't know if they were convinced to change their minds, or they generally just supported their decision.

LIZ BLACKLER: We did a little of both. I think in two of the situations, we were able to help families understand the nuances of the situation, and they agreed to a trial intubation. Other families were insistent that this was not in line with their loved one's wishes, which might have been separate from the COVID-19 pandemic.

One thing we did do with the hospitals early in the pandemic, we requested, mandated if you will, that all outpatient oncologists communicate and document the goals of care conversation with their patients on admission within 24 hours. And so each patient that was admitted to the hospital had a discussion. All those who could had discussions with their outpatient primary oncologist about diagnosis, treatment options at present, and what their wishes were regarding goals of care. And that very much helped the ethics consultation service and the services in the hospital provide care that was aligned with not only treatment options, but the patient's and family's wishes.

NATE PENNELL: That's really interesting. Because many people were listening to this podcast might think, well, gosh. Shouldn't you do that anyway when someone gets admitted to the hospital with advanced cancer? But perhaps the pandemic offered an opportunity, because patients were thinking about it now, as opposed to oftentimes when they get admitted and it suddenly is a bit of a shock to be presented with the question of what they would want if they needed to be resuscitated.

LIZ BLACKLER: Agreed. I think it's a natural opportunity for us to continue to strengthen our need for and goals of care conversations for all of our patients, whether they're stage one cancers or stage four cancers. And so I think it was this natural time where everybody was talking about it. And it just felt it was-- it was just made sense for us to do. And it is something that we've been trying to continue as a hospital. These conversations are hard to have. Patients and families are not always receptive. Clinicians are not always ready to have those conversation either. And so if anything, the pandemic brought us all together, and we all recognize in the anticipation of scarce resources how can we best take care of these patients. What's first and foremost is we have to have a better understanding of what our patient's wishes and preferences are.

NATE PENNELL: One of the things that continues, at least to some extent in a lot of places, is the restrictions on visitors and caregivers in the hospital, although perhaps not as strict as it was back in the spring. How did the inability of caregivers and powers of attorney and things like that to physically be present impact your job? And I guess more broadly, how does being forced to work over a sort of video conferencing impact these conversations?

LIZ BLACKLER: Sure. I think the level of distress secondary to the limited or lack of visitors at bedside, was palpable. So the nursing staff, the clinical staff, and non-clinical staff who were in the hospital at bedside every day were very upset. It was an incredibly sad time. And that in itself led to more ethics consultations, the amount of distress. And so we as a consultation service, worked hard in our virtual platform to provide extra support to staff who were trying to manage these patients to really take care of them in a way, in a kind and compassionate way in the midst of all of this chaos.

We started something called a virtual ethics open office hours. We actually set up a virtual Zoom twice a week where my consultants would sit on the Zoom call and just field questions, general questions that were coming up from staff. Because there was a lot of anticipation of what was to come, and how the hospital was prepared, how we were prepared to take care of patients, if we were to not have enough ventilators, or if we were not have enough blood products. And so the anticipation of all of that was very extremely stressful for staff, and I think compounded by the fact that there was no support at bedside for the patients.

I would say as a consultant service, going virtual certainly had its hiccups at first. But I actually think in the long run, we were able to really support patients and caregivers in a different way. There were more families that were able to participate in some of the family meetings, if they were scattered around the tri-state area or the country even. And so once everybody was acclimated to using these platforms, staff and family alike, then there were more opportunities for families to engage and participate in these family meetings. We were able to outfit many of our rooms with video access so that the patients who were able to participate were also able to participate, to be there [INAUDIBLE]

NATE PENNELL: It sounds like you did the best with what you could. And certainly it was tough on our patients, because they didn't have anyone to be there with them. But I can see the benefits of bringing people in who otherwise might have had trouble participating. So I wanted to just briefly touch upon something that I'm not sure if everyone realized this. But in anticipation of being completely inundated and running out of ventilators and whatnot, some hospitals were putting together protocols on how they would allocate resources. And it sounds like you may have been part of putting something like that together for your hospital. I know it was never needed. But can you talk a little bit about that?

LIZ BLACKLER: Sure. I think one of our obligations as an ethics committee is we have a duty to plan, and a duty to steward resources, and a duty to be transparent about it. So early in the pandemic, the ethics committee was asked to draft allocation policy in the event that we had a scarcity of equipment, or staff, resources, blood products. I remember being sent home from the office to start writing that policy. And I actually haven't been back since. What I will say is although an incredibly difficult policy to write, it was heart-wrenching for all of the reasons that you can imagine. It felt important to at least have a framework in place just in case. And so we made a decision as an ethics committee and consultation service to model the framework after the New York State ventilator guidelines that were published in 2015.

We made some slight modifications to address our unique cancer patient population. We chose the New York State guidelines, because they were developed just a few years before with support from our state government. The guidelines were also publicly available, and we assumed had passed with public support. There are no perfect guidelines. And so for us, in many ways we were lucky to have had a blueprint, something to work with in our state. While acknowledging that without state support, we were fully aware that if the crisis standards of care were needed, they needed to be implemented statewide with consistency.

We also struggled with trying to recognize that the policies needed to take into account inequities in access and delivery of health care, with special considerations for inherent bias, based on socioeconomic, racial, ethnic, age, and others with disabilities. I think as a bioethics community, we're working to update allocation policy that acknowledges and begins to rectify such bias. And so we're able to think about that now, looking back on what's happened a few months ago. But in real time, what we had with the New York state guidelines, which I think is a good start, those guidelines are your classic guidelines that look to maximize benefit of resource in order to save as many lives as possible.

The [INAUDIBLE] is given to patients for whom resources would most likely be lifesaving. We put into place a classic triage process that was grounded in a clinical scoring system. And we also made sure to remove the triage decisions from the bedside clinician, instead relying on a triage committee that would be made up of critical care physicians, administration, ethics consultants, or committee members, and other senior staff from the hospital to help make these determinations based on this clearly spelled out criteria, knowing that there were flaws in those criteria. And so we did put together a policy. We thankfully did not have to implement that policy. But we have the policy put into place.

NATE PENNELL: And that, I think, leads us really nicely into my last question, which is really what did you learn from all of this going forward? So if this happens again, hopefully not with COVID, but another emergency or something that leads to strained resources; what take-home lessons can you take from this that will make that perhaps an easier situation the next time?

LIZ BLACKLER: Sure I'll approach it from a macro and a micro standpoint. So within the hospital, one of the things that we learned is that our clinician's preoccupation and distress when confronted with these difficult choices in the pandemic, with the anticipation of a scarce resource, was palpable. And that as an ethics consultation service, we have an obligation to put together a center-based initiative to really support staff in real time. And so going virtual quickly, setting up services for staff that are proactive instead of reactive, it has been very helpful. And so I mentioned the virtual ethics clinics or office hours as one way to reach a lot of staff quickly, and to provide support in real time.

I think the other issue I touched on briefly, and that is working within the state and the country to come up with acceptable allocation policies that acknowledge bias, that acknowledged disparities in health care, and delivery of health care, and access to health care are extremely important. So one thing that has come out of this that I'm very proud of, as a hospital we at Memorial Sloan Kettering, we reached out to all of our colleagues in the city and upstate New York, and have recently just for formed an Empire State Bioethics Consortium. So all of the chairs of the bioethics departments from around the state, we now meet on a regular Monday night phone calls, to talk about what's happened, anticipation for future, and really working on a broad range of ethical issues that affect New York State.

NATE PENNELL: Liz, thank you so much for joining me on the podcast today.

LIZ BLACKLER: Thank you so much for having me. I really appreciate it.

NATE PENNELL: I'm glad we're going to have the opportunity to highlight your manuscript, which I think is really going to be beneficial to people who hopefully will not be presented with this in the future. But if they are, it's something to get them thinking. And until next time, I want to thank our listeners for listening to the JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple podcasts, or wherever you listen.

While you're there, be sure to subscribe, so you never miss an episode. JCOOP podcasts are just one of ASCO's as many podcast programs. You can find all the recordings at podcast.asco.org. And the full text of this paper is available online at ascopubs.org, backslash journal, backslash op. And this is Dr. Nate Pennell for the JCO Oncology Practice signing off. Thanks for listening.

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