Division of Hematology/Oncology, Department of Medicine, University of California, San Francisco, San Francisco, CA.
Helen Diller Family Comprehensive Cancer Center, San Francisco, CA.
JCO Oncol Pract. 2022 Jun;18(6):e915-e924. doi: 10.1200/OP.21.00328. Epub 2022 Feb 23.
Cancer clinical trial participants face considerable indirect costs associated with participation, such as travel and lodging, which may contribute to poor enrollment. Here, we report the findings in IMproving Patient Access to Cancer clinical Trials, a pilot feasibility study investigating the efficacy of offering a financial reimbursement program (FRP) during a therapeutic clinical trial discussion with or without additional outreach in improving patient enrollment.
Study participants for this study were recruited at two National Cancer Institute-designated comprehensive cancer centers (CCCs) from April 8, 2019, to September 19, 2019. Eligible participants were adults with a cancer diagnosis being approached to consider enrollment in a clinical trial. Participants were randomly assigned 1:1 to receive no follow-up (usual care) or a follow-up telephone call to facilitate FRP utilization stratified by study site. The target enrollment was 132 patients, with 66 patients in each study arm. The primary outcome was the consent rate to the multisite interventional study on the FRP among participants enrolling in clinical trials.
The study had a 78% consent rate and enrolled a total of 132 participants, of whom 51% were non-White compared with 28% of CCC treatment clinical trial participants in 2019. No difference in enrollment in clinical trials between the two study arms was observed as the proportion of enrollment was 70% for both study arms. The most common reason for not enrolling in a clinical trial was due to ineligibility determined through screening procedures (75%).
The current study observed that implementation of FRP at CCCs is feasible and serves a diverse patient population. Future studies will measure the impact of programs on overall clinical trial accrual and among racial/ethnic minorities.
癌症临床试验参与者面临与参与相关的相当大的间接成本，例如旅行和住宿费用，这可能导致参与率低。在这里，我们报告了在改善癌症临床试验患者准入（IMproving Patient Access to Cancer clinical Trials）中的研究结果，这是一项试点可行性研究，调查了在治疗性临床试验讨论中提供财务报销计划（FRP）的效果，无论是否有额外的外展工作，都可以提高患者的入组率。
本研究的研究参与者是从 2019 年 4 月 8 日至 9 月 19 日在两个美国国立癌症研究所指定的综合性癌症中心（CCCs）招募的。符合条件的参与者是被邀请考虑参加临床试验的癌症诊断成年人。参与者以 1:1 的比例随机分配，接受无随访（常规护理）或随访电话，以促进根据研究地点分层的 FRP 使用。目标入组人数为 132 名患者，每个研究臂 66 名患者。主要结果是参加临床试验的参与者对 FRP 的多站点干预研究的同意率。
该研究的同意率为 78%，共招募了 132 名参与者，其中 51%是非白人，而 2019 年 CCC 治疗临床试验参与者中只有 28%是非白人。两个研究臂之间的临床试验入组率没有差异，因为两个研究臂的入组率均为 70%。不参加临床试验的最常见原因是通过筛选程序确定的不合格（75%）。
目前的研究观察到，在 CCC 实施 FRP 是可行的，可以为不同的患者群体服务。未来的研究将衡量这些项目对总体临床试验入组率以及种族/族裔少数群体的影响。
