Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX, USA; Division of Hematology-Oncology, Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA; Department of Population and Data Sciences, UT Southwestern Medical Center, Dallas, TX, USA.
Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX, USA; Department of Population and Data Sciences, UT Southwestern Medical Center, Dallas, TX, USA.
Contemp Clin Trials. 2022 Oct;121:106922. doi: 10.1016/j.cct.2022.106922. Epub 2022 Sep 10.
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.
随着临床试验变得更加复杂，需要进行的程序和就诊次数也越来越多，许多人获得有前途的新治疗方法的机会变得更加困难。为了解决这些障碍，我们实施了一项财务报销和外展计划，旨在增加达拉斯、休斯顿和费城中心癌症临床试验的参与者数量和多样性。该计划得到了美国食品和药物管理局 (FDA) 和德克萨斯州和宾夕法尼亚州立法机构的认可，为收入不超过联邦贫困率 700%的癌症临床试验患者提供非临床费用（例如旅行、住宿）的财务报销。这里描述的研究集中在达拉斯站点，通过评估以下方面来评估计划的影响：(1) 在计划实施前后参加癌症临床试验的患者数量和多样性；(2) 参加该计划但未参加的患者的特征；(3) 参加该计划但未完成报销流程的患者的特征。为了评估参与计划的障碍和促进因素，我们将进行半结构化访谈，并使用全面财务毒性患者报告结果测量综合评分 (COST PROM) 和简短健康素养评估 (SAHL)。该计划将研究非临床费用的报销如何改善癌症临床试验的可及性，最终目标是增加试验的参与率、多样性、代表性和普遍性。
