The financial cost of cancer clinical trial participation.

Abstract

96 Background: Though financial hardship is a well-documented adverse effect of standard-of-care cancer treatment, little is known about out-of-pocket costs and their impact on patients participating in cancer clinical trials. This study explored financial effects of clinical trial participation. Methods: This cross-sectional analysis used survey data collected December 2022 and May 2023 from individuals with cancer previously served by Patient Advocate Foundation, a non-profit organization providing social needs navigation and financial assistance to individuals with a chronic illness. Surveys included questions on cancer clinical trial participation, trial-related financial hardship, and sociodemographic data. Descriptive and bivariate analysis were conducted using Cramer’s V to estimate in-sample magnitude of association. Multivariable analysis and inference on associations between financial hardship and sociodemographics was conducted using adjusted relative risks (aRR) and corresponding 95% confidence intervals (CI) from modified Poisson regression models with robust standard errors. Results: Of 650 survey respondents, 18% (N=118) reported ever participating in a clinical trial. Of those, 47% (n=55) reported financial hardship as a result of their trial participation. Respondents reporting trial-related financial hardship were more often unemployed or disabled (58% vs. 43%; V=.15), Medicare enrolled (53% vs. 40%; V=.15), and traveled >1 hour to their cancer provider (45% vs. 17%; V=.33) compared to respondents reporting no hardship. Respondents who experienced trial-related financial hardship most often reported expenses from travel (reported by 71% of respondents), medical bills (58%), dining out (40%), or housing needs (40%). Modeling results indicated that respondents traveling >1 hour vs. ≤30 minutes to their cancer provider had 2.2 times higher risk of financial hardship, even after adjusting for respondent race, income, employment, and insurance status (aRR=2.2, 95% CI 1.3-3.8). Most respondents (53%) reported needing $200-$1,000 per month to compensate for trial-related expenses. Over half (51%) of respondents reported less willingness to participate in future clinical trials due to incurred financial hardship. Notably, of patients who did not participate in a clinical trial (n=532), 13% declined participation due to cost. Conclusions: Cancer clinical trial-related financial hardship, most often stemming from travel expenses, affects almost half of trial-enrolled patients. Interventions are needed to reduce adverse financial participation effects and potentially improve cancer clinical trial participation. These would likely include increased compensation, broader reimbursement for expenses, or changes to trial design that minimize travel and other financial burdens.