The Texas Clinical Trials Participation Program—helping cancer patients overcome the financial toxicity of clinical trials
Introduction
Cancer patients face numerous barriers to participation in clinical trials, including stringent eligibility criteria and complex screening and study procedures. To complete these study procedures, patients considering clinical trials often need to travel to study centers more often than patients receiving standard therapies. In some cases, study centers may be located far from patients’ homes. Both factors may result in increased travel time and expenses. Given the financial burden inherent to a cancer diagnosis, our Texas Clinical Trials Participation Program aims to remove the out-of-pocket expenses related to ancillary costs such as travel, lodging, and meals which may pose a barrier to trial participation.
Methods
We developed a Trial Participation Program following FDA, state (HB 3147, 86th Texas Legislature), and CPRIT guidance. In this program, cancer patients residing in Texas with household income up to 700% of the Federal Poverty Level (e.g., $210,000 for a household of four) can receive reimbursement for transportation (commercial, rideshare, fuel, etc.), lodging, and meals, with reimbursement rates ranging from 50%-100% of costs according to income. For travel >50 miles, expenses for a companion can also be reimbursed. Certain other costs (e.g., childcare in a licensed facility or in-home care able to provide adequate documentation for tax purposes, internet access for telehealth visits) are also considered. We implemented the program at the clinical sites of the Harold C. Simmons Comprehensive Cancer Center, including UT Southwestern Medical Center, Parkland Health (the integrated safety-net healthcare provider for Dallas County), and Children’s Medical Center Dallas. Simmons Cancer Center staff oversee and assist with participant identification, referral, enrollment, and submission of receipts. The Lazarex Cancer Foundation, which operates out-of-pocket expense reimbursement programs for trial participants at other sites, oversees the confirmation of participant eligibility and distribution of reimbursement funds. To evaluate the reimbursement program, a study is being conducted which includes surveys and semi-structured interviews with those who consent to participate. Participation in the program evaluation study is not required for reimbursement program participation.
Results
The Program was initiated in June 2022. As of June 2023, 246 patients (66% non-Hispanic White, 20% Hispanic, 10% non-Hispanic Black) had been referred, of whom 83 were enrolled (43% non-Hispanic White, 39% Hispanic, 9% non-Hispanic Black). Of the remaining 163 patients, 54 (33%) declined to participate, 52 (32%) were found to be ineligible, 15 (9%) could not be reached despite multiple attempts, 22 (14%) were in the process of enrollment, and 20 (12%) were awaiting initial contact from the program team. Ineligibility reflected disqualification for the financial reimbursement program and/or failure to qualify for/enroll in a therapeutic cancer clinical trial. As of April 2023, a total of 134 reimbursements had been issued, totaling $48,180 (average $360). As of July 2023, preliminary survey responses were available for 58 patients, of whom 40% reported feeling quite or very financially stressed and 63% reported feeling very confident about filling out medical forms by themselves.
Conclusion
Reimbursement of out-of-pocket costs for patients on cancer clinical trials is feasible across healthcare settings, including a university-based medical center, a safety-net system, and a pediatric hospital. Because a substantial proportion of cancer patients feel financially stressed, such programs may improve the reach, diversity, and generalizability of clinical trials.