Financial reimbursement for clinical trial participation costs: A pilot feasibility study.

93 Background: Clinical trial participants rarely represent the real-world treatment population. Monetary reimbursement for trial-related costs could dismantle financial barriers to trial recruitment and retention, allowing for more diverse trial samples. Methods: This mixed-methods, pilot, feasibility study provided financial reimbursement to women with breast cancer participating in a clinical trial at the University of Alabama at Birmingham. Patients were reimbursed $1,000/month during their first four months of trial participation and surveyed biweekly to assess changes in financial toxicity using the COmprehensive Score for financial Toxicity (COST; scored 0-44, lower scores indicate worse financial toxicity). After the four-month period, patients were interviewed to explore the effects of receiving reimbursement on trial-related costs and trial recruitment and retention. Mixed modeling and thematic analysis were completed for the quantitative and qualitative data collected, respectively. Feasibility was defined as 80% retention of patients, with those retained completing 75% of surveys. Results: Of 39 consented patients, 33 patients completed the pilot study (85% retention, 100% survey completion). Patients were a median 52 years old (IQR 44-59), 48% Black, 67% privately insured, and 42% found it difficult to live on their current household income. Patient financial toxicity modestly decreased over the course of the study (COST β = 1.4, 95% CI -0.7-3.4), with Black patients having greater decreases in financial toxicity compared to White patients (COST β = 2.4, 95% CI -0.7-5.4 vs. β = 0.3, 95% CI -2.6-3.1). The majority of patients reported using the reimbursement to pay for trial-related food (89% groceries, 61% restaurants while at trial visits, 32% specialty foods due to receiving treatment), transportation (75% gas, 29% parking, 11% hotel, 11% car maintenance), caregiver expenses (43% caregiver support, 25% childcare), and out-of-pocket medical costs (50% cost-sharing, 29% prescriptions, 21% supportive care). Patients felt that receiving reimbursement affected trial retention more so than recruitment, stating “I would have enrolled regardless...[but] knowing that even if it was difficult to find childcare, it wasn’t going to place a financial strain on us because of these reimbursements, that definitely made it less stressful...It made it easier for me to feel good about continuing with the trial.” Conclusions: Reimbursement for clinical trial-related costs is feasible, suggested decreases in financial toxicity, and is a promising approach to improve trial retention outcomes in women with breast cancer.