Recruitment of a diverse participant pool to cancer clinical trials is an essential component of clinical research as it improves the generalizability of findings. Investigating and piloting novel recruitment strategies that take advantage of ubiquitous digital technologies has become an important component of facilitating broad recruitment and addressing inequities in clinical trial participation. Equitable and inclusive recruitment improves generalizability of clinical trial outcomes, benefiting patients, clinicians, and the research community. The increasing prevalence of online connectivity in the USA and use of the Internet as a resource for medical information provides an opportunity for digital recruitment strategies in cancer clinical trials. This study aims to measure the acceptability, preliminary estimates of efficacy, and feasibility of the Trial Library intervention, an Internet-based cancer clinical trial matching tool. This study will also examine the extent to which the Trial Library website, designed to address the linguistic and literacy needs of broader patient populations, influences patient-initiated conversations with physicians about clinical trial participation. This is a study protocol for a non-randomized, single-arm pilot study. This is a mixed methods study design that utilizes the statistical analysis of quantitative survey data and the qualitative analysis of interview data to assess the participant experience with the Trial Library intervention. This study will examine (1) acceptability as a measure of participant satisfaction with this intervention, (2) preliminary measure of efficacy as a measure of proportion of participants with documented clinical trial discussion in the electronic medical record, and (3) feasibility of the intervention as a measure of duration of clinical visit. The principles that informed the design of the Trial Library intervention aim to be generalizable to clinical trials across many disease contexts. From the ground up, this intervention is built to be inclusive of the linguistic, literacy, and technological needs of underrepresented patient populations. This study will collect essential preliminary data prior to a multi-site randomized clinical trial of the Trial Library intervention. This study has received institutional approval from the Committee of Human Subjects Research at the University of California, San Francisco.

中文翻译：

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迈向公平临床试验招募的一步：在线前列腺癌健康信息和临床试验匹配工具的开发和初步测试协议

为癌症临床试验招募多元化的参与者是临床研究的重要组成部分，因为它提高了研究结果的普遍性。调查和试行利用无处不在的数字技术的新招募策略已成为促进广泛招募和解决临床试验参与不公平问题的重要组成部分。公平和包容的招募提高了临床试验结果的普遍性，使患者、临床医生和研究界受益。美国在线连接的日益普及以及互联网作为医疗信息资源的使用为癌症临床试验中的数字招募策略提供了机会。本研究旨在衡量可接受性、疗效的初步估计、试验图书馆干预的可行性和可行性，这是一种基于互联网的癌症临床试验匹配工具。本研究还将检查旨在满足更广泛患者群体的语言和识字需求的试验图书馆网站在多大程度上影响患者发起的与医生就临床试验参与进行的对话。这是一项非随机、单臂试验研究的研究方案。这是一个混合方法研究设计，利用定量调查数据的统计分析和访谈数据的定性分析来评估参与者对试验图书馆干预的体验。本研究将检验 (1) 可接受性作为参与者对该干预的满意度的衡量标准，(2) 疗效的初步测量，作为电子病历中记录临床试验讨论的参与者比例的测量，以及 (3) 作为临床访问持续时间测量的干预的可行性。为试验图书馆干预设计提供依据的原则旨在推广到许多疾病背景下的临床试验。从头开始，这种干预措施旨在涵盖代表性不足的患者群体的语言、识字和技术需求。本研究将在试验图书馆干预的多地点随机临床试验之前收集必要的初步数据。这项研究已获得加州大学旧金山分校人类受试者研究委员会的机构批准。