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Ashish Kamat: Hello, and welcome to UroToday's bladder cancer center of excellence. I'm Ashish Kamat, Professor of Urologic Oncology and Cancer Research at MD Anderson Cancer Center. And it is a distinct pleasure to welcome today, Dr. Sumeet Bhanvadia, from The University of Southern California. Dr. Bhanvadia is the recipient of the BCAN Young Investigator Award and presented her talk this year at the virtual BCAN Think Tank session, a really stimulating discussion that ensued after that as well. And I'm really pleased that she has taken the time to join us today and share her thoughts on "understanding the burden and impact of financial toxicity amongst a diverse population of bladder cancer patients" with our audience today. So Sumeet with that, I'll hand the stage over to you.

Sumeet Bhanvadia: Thank you, Dr. Kamat and UroToday for having me here to talk about my project, which is entitled, Understanding the Burden and Impact of Financial Toxicity Among a Diverse Population of Bladder Cancer Patients. So a little background, what is financial toxicity? Well, financial toxicity is a term that describes the negative financial impact of a cancer diagnosis on the household patient-reported outcome, and there is a three-domain model of financial hardship that is generally accepted in this area. The first domain is material conditions such as debt, which we consider direct costs as well as reduced or lost income, which we consider indirect costs of care. The second is the psychological response that these material conditions elicit such as financial worry or distress. And the third domain is the coping strategies that patients and their families employ as they try to deal with this. And this includes delaying or even forgoing cancer care.

Well, why does this matter? Financial toxicity in the literature has been associated with declines in quality of life, non-adherence, and may even in certain situations, be an independent predictor of mortality. So in terms of how it impacts cancer outcomes, these are just a few examples of some large studies. So in one study oversampled for Blacks and Latinos, one in six cancer patients in America reported delaying or foregoing care due to financial concerns, which translates to greater than two million cancer survivors, nationally. Patients with severe financial hardship in one study have been shown to have a 79% increased risk of mortality. And there are multiple studies that cumulatively suggest that women, Blacks, Latino, patients with low income, and low educational attainment may represent high-risk groups to developing financial toxicity.

So overall, the study of financial toxicity is a critical unmet need for two reasons. One, financial toxicity is a key domain in survivorship. And secondly, it seems to be a key determinant of outcomes. Furthermore, both ASCO and the NCI say that physicians, whether those be medical oncologists or surgical oncologists, should be the stewards in terms of preparing patients for the financial hardship or the financial burden that may ensue when we are recommending cancer treatments. Well, why does this matter particularly in bladder cancer? This table is just an example of the aspects of bladder cancer survivorship that we know are unique and carry a heavy burden for patients. They include physical effects, psychosocial effects, as well as direct economic effects. We know that in bladder cancer, there are high direct and indirect, indirect being things like lost wages and productivity costs. We know that there are significant declines in quality of life and rates of depression that are higher than we see in other cancer sites. And we also know from the limited data that we have, that financial toxicity is actually quite common among bladder cancer patients.

There are two published studies that we can turn to in regards to this, both of which are cross-sectional. And in both, they show that social determinants such as age, race, income, and insurance type appear to be more closely associated with financial toxicity. So overall, the problem is that the data that we have in bladder cancer about financial toxicity is cross-sectional and survey-based. So there is only so much that we can know from the published data that we have. So we proposed and we are fortunate enough to get funded to conduct a pilot study at the USC Norris Comprehensive Cancer Center. My mentors are Dr. Reginald Tucker-Seeley, Dr. Siamak Daneshmand, and Dr. Ricky Bluthenthal. And this was initially supported by a BCAN Young Investigator Award and subsequently a Wright Foundation Pilot Award through USC.

Our goals were to first identify the social and clinical determinants of financial toxicity among a diverse sample of bladder cancer patients at both our very busy county hospitals, as well as at our tertiary private cancer center. Our hypotheses were that social determinants would drive financial toxicity and that greater time from diagnosis would correlate to greater financial toxicity. And secondly, to characterize the impact of financial toxicity on quality of life over time. And our hypothesis here was that financial toxicity would drive declines in quality of life. So we enrolled 100 bladder cancer patients from these two sites I described, and we collected granular socio-demographic variables, as well as clinical pathologic variables. We performed baseline assessments of financial toxicity, quality of life, and an assessment about delaying or foregoing care. So this was a cross-sectional study. We included high-risk, non-muscle-invasive, and muscle-invasive patients. And we performed quantitative assessments as well as qualitative assessments via semi-structured interviews. Furthermore, we conducted a short-term longitudinal study across a year where we repeated these measures to see how they changed over time or stayed stable.

We took two measures of financial hardship. One is a validated measure called the Comprehensive Score for Financial Toxicity validated in cancer patients that are seen here and a second instrument that is a free publicly available instrument through the Consumer Financial Protection Bureau, which is a survey of financial wellbeing. And our measure of health-related quality of life was FACT-BL. So our results in terms of our patient characteristics, you can see here that we had a pretty diverse group in terms of race with almost 3/4 of the patients being nonwhite. The primary language spoken, about 22% of our patients spoke Spanish as a primary language. As well we had good distribution across levels of education. As anticipated in a bladder cancer population, approximately 50% of patients were fully retired. And you can see here that we had a good spread of annual income as well.

Overall, we ended up with 79 patients from the tertiary private cancer center and 21 patients from LA County. When we looked at both the COST and CFPB scores, we could see that there was a fairly normal distribution across sites. And when we looked at our bivariate analysis, trying to find associations between financial toxicity and patient characteristics, the ones that we found with associations were the social care, social determinants, education, race, as well as facility type with those being treated at the county facility, having higher financial toxicity scores, which was not surprising. What was slightly surprising was that we did not find any associations more or less, between clinical or treatment variables and financial toxicity scores. The exception to this was the receipt of neoadjuvant chemo, which was associated with slightly higher financial toxicity scores. But this was a weak association.

On multivariable analysis, when we plugged in these social determinants, we found that these factors were not significant. Well, we then went on to investigate the impact of time on financial toxicity. And overall, we found that time since diagnosis was not statistically significantly associated with total COST or CFPB scores. But when we looked at individual items, we found that patients who had been diagnosed one year or more had higher odds of reporting, not feeling in control of their current financial situation as compared to those diagnosed within a year. We went on to ask the question, what is the impact of financial toxicity on quality of life? Of note, there is a lack of published thresholds that are significant for financial toxicity across either of these instruments or truly for the FACT-BL across the spectrum of bladder cancer patients, which truly was our population that span from high-risk non-muscle invasive to metastatic bladder cancer.

So we define high financial toxicity as above the 75th percentile. And we use the study mean of the FACT-BL instrument. And what we found was that the psychological domains of the COST score or the financial toxicity measure were associated with the physical domain scores of FACT-BL. And you can see this here, but I will say that we had quite wide confidence intervals, which also I think reflects the size of our study, which was quite small, at 100 patients. We then asked, do financial toxicity scores and quality of life scores change over a year. And this is an interim analysis of just 35 patients. And what we found was that both quality of life measures and financial toxicity measures, as well as the financial well-being measures, all remained stable across the year. So our take home from this was that patients have a baseline, but risk of financial toxicity or vulnerability to developing financial hardship as they navigate cancer care. And that this is driven by social and not clinical determinants.

So as we were in the midst of our study, COVID-19 hit and we found ourselves asking patients about financial hardship in the middle of the pandemic, which was complicated. So we added some of these COVID-19 questions to try to tease out what was in terms of financial hardship, what was being driven by COVID-19 and the pandemic, and what was being driven by their cancer care. And you can see these questions that we asked here. And again, an interim analysis, the two questions that we found were associated, were does the current COVID-19 pandemic make you more concerned about your financial security? In general, we found that to be associated with both financial toxicity instruments. And when we asked does the current COVID-19 pandemic makes you more concerned about your financial security in relation to your bladder cancer care, this was associated with the financial wellbeing instrument scores.

So our take home from this was that patients who were vulnerable to financial hardship from COVID-19 were those that had a baseline financial hardship. So overall our take-home messages are that financial toxicity is common across bladder cancer patients, regardless of facility type. That social determinants rather than clinical or treatment factors appear to drive financial toxicity. That aspect of financial hardship impacts aspects of quality of life. And that financial toxicity measures seem to remain stable over a year, suggesting that a single baseline screening is a valid approach. We have several pending analyses, including qualitative data of 25 semi-structured interviews with patients who had those high baseline scores, as well as the one-year analyses of our complete cohort. We have several important limitations. This study is a small cohort. There is significant clinical heterogeneity here that may have hindered us from identifying clinical and treatment factors associated with financial toxicity.

And we had a quite high loss to follow-up rates of 25% in one year, which were certainly related to the fact that most visits became remote visits at some point during our study. Next steps, we've submitted a grant to the NCI to better and to more deeply delve into the findings that we had. This will include an assessment of both patients, as well as their caregivers to identify patient and health system factors associated with increased financial toxicity. Using a mixed-method approach, we will further delve into the association of financial toxicity with quality of life and treatment adherence, and ultimately develop and test the feasibility of a multi-level clinic-based intervention to mitigate financial toxicity among newly diagnosed bladder cancer patients. For this, I'm very grateful that we have found some great partners. In addition to our diverse patient population at USC, we will be including patients from the CISTO study, which is a national study of many sites, as well as the Patient Survey Network through BCAN.

As you can see here, there are many levels that drive financial toxicity, and we hope to delve further and more deeply into many of these, including from the employer level. When we talk about an intervention, we need to think about what should an intervention look like? What is feasible insight from the clinic and what is feasible outside of it? And we will take both patient and family perspectives as well as physician perspectives as to what is really feasible as providers in terms of our guidance and our counseling. Thank you very much for listening.

Ashish Kamat: That was great. Really nicely done. Thank you so much for doing that. Obviously, you outlined the next steps, which would have been one of my questions. I'm glad you put that in there in the slide format as well. But if you take what you learned thus far and things obviously that you put thought into moving forward for your next steps, what are some of the lessons or pearls you would want to share with the folks that are listening right now that they could kind of incorporate, or at least keep at the back of their clinical practice flow when considering different options with patients?

Sumeet Bhanvadia: Yeah. Well, I set out to do this study, looking at it very much from a clinician and surgical perspective. My ultimate goal was to find solutions and find ways to mitigate this. And I think we still do not have the full answers yet to decide and to sort of design that mitigation. But the things that did come out from this that are consistent with the limited data we have is that the patients come in with a certain baseline vulnerability. And secondly, that whatever that vulnerability is, you really can assess that at the time that you meet them, at the time of diagnosis, and really use that to guide the support that we give them. So my thought is that something like an initial screening tool, even perhaps in the urology clinic that then streamlines patients to financial navigation services could be quite useful.

The other thing that's come out that I didn't present yet because our data isn't quite ready for that yet. But the thing that comes out of our interviews is that financial hardship is a sort of subjective thing. And even patients with resources can feel the brunt of some sort of financial instability in different ways. And in our mainly retired population, it can take forms that we may not think of. It might not mean that they're not able to pay their medical bills, but it might mean that they're retiring early, that they're dipping into their saved assets, or that they're changing their plans in terms of the wealth they may be leaving behind for future generations. And those things can also cause a lot of stress in patients and also impact the treatment choices that they make. So I think it's really multifactorial. I'm excited to dive a little deeper in a bigger patient population to this, but I do think that ultimately, we will find a feasible way to do that one-time assessment that may not solve all issues, but we will certainly be able to direct patients to good resources from the beginning.

Ashish Kamat: That's a great point. As part of the think tank, you also lead the workshops for attendees. And one of the things that you mentioned is not related to this talk specifically, but if you could bring that into this, how would you consider this when it comes to the design and conduct of clinical trials?

Sumeet Bhanvadia: Yeah, I think that's an excellent question. I mean, as clinicians, we know that for certain patients, it's not just a socioeconomic status thing, but it's also a morality versus the urban center type of issue. And there are many barriers for patients to access clinical trials, whether it be the cost of, the therapies that might be covered, but the cost of transportation and the indirect cost to the family, whether it be that they are driving in from three hours away. And so a trial protocol that is quite burdensome in terms of visits may make that an option that is not open to them at all. I think when we talk about more and more, we talk about telemedicine and how that increases access. I think we need to be creative and really almost proactive or even aggressive about implementing and incorporating some of those sorts of remote visits into our clinical trial designs. If we really truly are committed to increasing diversity in our clinical trials and making access to clinical trials, sort of more egalitarian.

Ashish Kamat: Great. And again, this is such an important topic that I'm glad that you took this upon yourself to champion. Congratulations again on the award. And I'll leave you with the last 30, 60 seconds, some high-level closing thoughts for our audience that were listening in, any message you want to leave them with, kind of like a take-home message.

Sumeet Bhanvadia: I think as cancer providers, we focus rightly so on providing the most sort of personalized and high-level data-driven care that we can to patients. But I think we need to also be very mindful of the pragmatics of administering cancer care and the burdens that that may put on patients and their families. And we need to acknowledge that we may not always be the people that patients and their families feel most comfortable in voicing these concerns too. And that's okay. I think our role should be to be cognizant of these things and to be cognizant of the fact that cancer care is burdensome and is costly. And to certain patients, as we know, the statistics would say, cause significant financial hardship. And we need to be focused on that and cognizant of that, and really support efforts to bring in other services such as social workers and financial navigators to help us help our patients best.

Ashish Kamat: Right. Again, Sumeet, thank you so much for taking the time. Really well deserved. Congratulations. And I'm sure we will hear a lot more from you on this topic in the months and years to come.

Sumeet Bhanvadia: Thank you so much.