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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., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dana L.Dornsife is Founder, Chief Mission and Strategy Officer, Lazarex Cancer Foundation., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To determine the association between functional health literacy and physical and mental health status in a sample of Latinos and African Americans., Methods: A cross-sectional study that used a demographics questionnaire, the Short Test of Functional Health Literacy in Adults (S-TOFHLA), the physical component summary (PCS-12) and mental component summary (MCS-12) scales of the SF-12, and the Charlson Comorbidity Index in a sample of 1301 Medicaid and/or Medicare Latino and African American adult patients at four community clinics and one university-based general medicine practice in Philadelphia., Results: When stratified by inadequate, marginal, and adequate functional health literacy levels and compared to SF-12 population norm scores of 50.0, the mean (standard deviation [SD]) PCS-12 scores were 38.8 (11.2), 38.5 (11.1), 42.7 (11.4), respectively (P < .0001); the mean (SD) MCS-12 scores were 43.3 (11.2), 43.5 (10.4), 44.3 (11.7), respectively (P = .39). After adjusting for sociodemographic confounders and Charlson Index score, functional health literacy was not significantly associated with physical or mental health status (P > .50 and P = .41, respectively)., Conclusion: Functional health literacy is not independently associated with perceived physical health status or mental health status in a sample of ethnic minorities.