Abstract

e18568 Background: Financial reimbursement programs (FRP) aim to address patients’ out-of-pocket expenses associated with clinical trial participation. The study aims to explore patients’ experience in therapeutic clinical trials (TCT) after enrollment in FRP at two academic medical centers in California and identify barriers and opportunities to improve TCT participation. Methods: From May 2019 to January 2020, adult patients with a diagnosis of cancer and eligible for a TCT were recruited from oncology clinics. Eligible participants for the FRP had a household income ≤ 700% of the current HHS Poverty Guidelines. Semi-structured interviews were conducted in patients’ preferred language. Qualitative analysis was performed comparing experiences by site and by preferred language. An iterative process of coding was used to identify themes on interview transcripts. Results: 53 patients were interviewed (20, UCSF; 33, USC). Median age was 59 (IQR 46 - 65) and 59% were female. Nearly half (49%) identified as Latinx/Hispanic compared to 32% Non-Hispanic White, 10% Asian, 4% Black, 1% Native American, and 4% Other. A third were non-English speakers (68% English, 26% Spanish, 6% Korean/Other), 42% had a college education or more, and 55% were retired/unemployed. The majority of patients (66%) had metastatic disease. Patients described their commute to the TCT sites which involved complex logistics and commute time ranging from one hour to 4.5 hours as well as numerous out-of-pocket costs. Prominent barriers to TCT participation included financial toxicity, fears of the process itself or the low likelihood of cure, and systemic factors affecting enrollment. Despite these barriers, most patients would participate in a TCT regardless of financial hardship. Patients proposed modifications to TCTs including decentralization, recruitment strategies, education and peer counseling as well as vouchers and established rates for out-of-pocket expenses. While English-speaking patients were varied on willingness to discuss financial concerns with their doctors, the majority of non-English speakers reported that they would speak with their physician about financial concerns associated with treatment. Conclusions: Patients’ experiences with TCTs demonstrate a combination of financial and logistical stressors that may be lessened by financial reimbursement programs. FRPs have the potential to address inequities in clinical trial access among vulnerable populations.

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