Addressing the Financial Burden of Cancer Clinical Trial Participation: Longitudinal Effects of an Equity Intervention

Nipp, Ryan David; Lee, Hang; Gorton, Emily; Lichtenstein, Morgan Rl; Kuchukhidze, Salome; Park, Elyse R.; Chabner, Bruce A.; Moy, Beverly

doi:10.1634/theoncologist.2019-0146

Cited by 47 publications

(44 citation statements)

References 38 publications

(52 reference statements)

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“…The median value in our study was 20, indicating worse financial toxicity than that seen in prior studies of patients enrolled in clinical trials, in which the median FTS was 24, and in insured patients with multiple myeloma, in which the median FTS was 23. 13,25 This finding is consistent with a prior study reporting that the prevalence of high financial burden (indicated by COST FTS ≤ 24) was more than two-fold higher among phase I clinical trial patients (67%) than among oncology patients treated with curative-intent surgery (30%). 26 Patients used a variety of means to pay for their clinical trial-related expenses.…”

Section: Discussionsupporting

confidence: 90%

“…To date, there is limited evidence regarding financial toxicity for patients enrolled in clinical trials, with only one prior study examining the role of an equity intervention for patients with cost concerns. 13 We found that financial toxicity was higher for patients with income ≤$60,000 and for patients who traveled farther to receive their care. These data build on existing knowledge that both of these groups are underrepresented in clinical trials, 5 suggesting that both groups have barriers to entry into clinical trials and additional financial concerns after enrollment.…”

Section: Discussionmentioning

confidence: 72%

“…One prior study that evaluated a reimbursement intervention for some clinical trial-related expenses did not find improvement in patients' financial well-being over time. 13 Moving forward, more research is needed to better understand how to relieve financial toxicity for patients enrolled in clinical trials. Future research should explore potential mechanisms to reimburse out-of-pocket expenses for patients in clinical trials.…”

Section: Discussionmentioning

confidence: 99%

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Patient-Reported Out-of-Pocket Costs and Financial Toxicity During Early-Phase Oncology Clinical Trials

et al. 2021

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Background. Clinical trials are an important therapeutic option for cancer patients. Although financial burden in cancer treatment is well-documented, the financial burden associated with clinical trials is not well understood. Patients and Methods. We conducted a survey regarding economic burden and financial toxicity in cancer patients enrolled in Phase I clinical trials for >1 month. Financial Toxicity Score (FTS) was assessed using the Comprehensive Score for Financial Toxicity (COST) survey. Patients also reported monthly out-of-pocket (OOP) costs. Results. 213 patients completed the survey (72% non-Hispanic white, 45% with annual income ≤$60,000, 50% lived >300 miles from the clinic; 37% required air travel). 48% of patients had monthly OOP costs of at least $1000. 55% and 64% of patients reported unanticipated medical and non-medical expenses, respectively. Worse financial toxicity was associated with yearly household income < $60,000 (OR: 2.7, P=0.008), having unanticipated medical costs (OR: 3.2, P=0.024), and living >100 miles away from the clinical trial hospital (OR: 2.3, P=0.043). Nonwhite or Hispanic patients (OR: 2.5, P=0.011) and patients who were unemployed or not working outside the home (OR: 2.5, P=0.016) were more likely to report high unanticipated medical costs. Conclusion. Among cancer patients participating in clinical trials, economic burden is high, and most of patients' OOP costs were non-medical costs. Financial toxicity is disproportionally higher in patients with lower income and those who travel farther, and unexpected medical costs were more common among nonwhite or Hispanic patients. OOP costs can be substantial and are often unexpected for patients. The Oncologist 2021;9999:• • Implications for Practice: The financial burden of cancer treatment is well-documented but there is limited data regarding the financial burden associated with cancer clinical trials. We surveyed 213 patients enrolled on early-phase clinical trials. Monthly out-of-pocket non-medical expenses were $1,075 and medical expenses were $475. Worse financial toxicity was associated with income <$60,000 and living farther away from the hospital. Racial/ethnic minorities had higher rates of unanticipated medical costs. These data help to quantify the high financial burden for patients and may reveal a cause of disparities in clinical trial enrollment for underrepresented populations.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 72%

Section: Discussionmentioning

confidence: 99%

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Patient-Reported Out-of-Pocket Costs and Financial Toxicity During Early-Phase Oncology Clinical Trials

et al. 2021

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“…Many studies have used questions to identify patients with FT that focus on indirect costs of cancer care (eg, travel, lodging, and employment) rather than questions that evaluate the ability of the patient to financially manage their basic needs of living (eg, medicines, food, and clothing), which is more relevant to older adults with limited incomes. 10,15,16 In this secondary analysis of a large national clinical trial, we aimed to (1) estimate the prevalence of FT in older patients with advanced cancer enrolled in a clinical trial, (2) examine the association between FT and HRQoL, and (3) describe cost conversations between oncologists and patients with FT. We hypothesized that FT was associated with worse HRQoL.…”

Section: Introductionmentioning

confidence: 99%

Assessment of Financial Toxicity Among Older Adults With Advanced Cancer

et al. 2020

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IMPORTANCE Financial toxicity (FT), unintended and unanticipated financial burden experienced by cancer patients undergoing cancer care, is associated with negative consequences and increased risk of mortality. Older patients (Ն70 years) with cancer are at risk for FT, yet data are limited on FT and whether oncologists discuss FT with their patients. OBJECTIVE To examine the prevalence of FT in older adults with advanced cancer, its association with health-related quality of life (HRQoL), and cost conversations between oncologists and patients. DESIGN, SETTING, AND PARTICIPANTSThis cross-sectional secondary analysis was performed on baseline data from the Improving Communication in Older Cancer Patients and Their Caregivers study, a cluster randomized trial from 31 community oncology practices across the US that was

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“…ASCO assembled a Cancer Trial Accrual Symposium in 2013, with recommendations in favor of promoting equity in accrual by providing financial support, engaging with patients and providers in minority and/or under-resourced communities, and incentivizing physician involvement. 9 Community-based pilot programs implementing these recommendations have begun operating successfully, 10 and digital media platforms like TheMedNet hold promise in connecting patients and providers to active trials with which they may not otherwise have been familiar.…”

mentioning

confidence: 99%

Cancer Clinical Trial Enrollment: OK Doc, but What’s in It for Me?

Park¹

2019

Journal of the National Comprehensive Cancer Network

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Addressing the Financial Burden of Cancer Clinical Trial Participation: Longitudinal Effects of an Equity Intervention

Abstract: Financial barriers may discourage some patients with from participating in cancer clinical trials. This study sought to assess the effect of an equity intervention on the financial burden of clinical trial participants.

Cited by 47 publications

References 38 publications

Patient-Reported Out-of-Pocket Costs and Financial Toxicity During Early-Phase Oncology Clinical Trials

Patient-Reported Out-of-Pocket Costs and Financial Toxicity During Early-Phase Oncology Clinical Trials

Assessment of Financial Toxicity Among Older Adults With Advanced Cancer

Cancer Clinical Trial Enrollment: OK Doc, but What’s in It for Me?

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