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As clinical trials have become more complex, with increasing numbers of required procedures and clinic visits, gaining access to promising new treatments has become even more challenging for many individuals. To address these barriers, we implemented a financial reimbursement and outreach program designed to increase the number and diversity of participants in cancer clinical trials at centers in Dallas, Houston, and Philadelphia. As endorsed by U.S. Food and Drug Administration (FDA) and the Texas and Pennsylvania State Legislatures, the program provides financial reimbursement for non-clinical costs (e.g., travel, lodging) to patients on cancer clinical trials with household income up to 700% the Federal poverty rate. The research study described here, centered at the Dallas site, evaluates program impact by assessing (1) numbers and diversity of patients enrolled to cancer clinical trials before and after program implementation; (2) characteristics of patients offered participation in the program who do versus do not enroll; (3) characteristics of patients enrolled in the program who do versus do not complete the reimbursement process. To evaluate perceived barriers and facilitators of program participation, we will conduct semi-structured interviews and administer the Comprehensive Score for Financial Toxicity Patient Reported Outcome Measure (COST PROM) and the Short Assessment of Health Literacy (SAHL). This program will examine how reimbursement of non-clinical costs can improve access to cancer clinical trials, with the eventual goal of increasing trial enrollment, diversity, representativeness, and generalizability. [ABSTRACT FROM AUTHOR]

Objective: The introduction of oral cancer therapies presents new challenges to delivery of quality cancer care. Little is known about how patients and providers address and overcome these challenges. We conducted a qualitative study exploring the range of patient and provider perspectives on oral cancer therapies.Methods: We conducted semi-structured interviews with patients and providers at a tertiary referral center and county safety-net hospital in Dallas, TX. Interviews probed perspectives on differences between parenteral chemotherapy and oral therapies, adherence, communication, and cost/insurance. Interview transcripts were analyzed thematically using a deductively-driven coding scheme corresponding to the interview guide.Results: We conducted 22 patient (13 at tertiary referral center, 9 at safety-net hospital) and 10 provider (7 oncologists, 2 nurses, 1 pharmacist) interviews. Key themes from interviews included: (1) differences in parenteral chemotherapy vs. oral therapy; (2) adherence and dosing; and (3) experiences related to cost and communication.Conclusions: Nearly all providers described challenges engaging with and educating patients about oral cancer therapies. Despite our initial hypothesis, safety-net patients encountered few barriers accessing oral therapies compared to patients receiving care in the tertiary referral center.Practice Implications: Our findings will guide future interventions to monitor and support cancer patients receiving oral therapies. [ABSTRACT FROM AUTHOR]