Borno Hala T, Bakke Brian M, Kaplan Celia, Hebig-Prophet Anke, Chao Jessica, Kim Yoon-Ji, Yeager Jan, Cinar Pelin, Small Eric, Boscardin Christy, Gonzales Ralph
1Department of Medicine, Division of Hematology/Oncology, University of California at San Francisco, 550 16th Street, 6th Floor, Box 3211, Office 6554, San Francisco, CA 94158 USA.
2School of Medicine, University of California at San Francisco, San Francisco, USA.
Pilot Feasibility Stud. 2019 Nov 7;5:123. doi: 10.1186/s40814-019-0516-4. eCollection 2019.
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.
招募多样化的参与者群体参与癌症临床试验是临床研究的重要组成部分，因为这能提高研究结果的普遍性。研究和试点利用无处不在的数字技术的新型招募策略，已成为促进广泛招募和解决临床试验参与不平等问题的重要组成部分。公平和包容性的招募可提高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将互联网用作医疗信息资源，为癌症临床试验中的数字招募策略提供了机会。本研究旨在衡量试验库干预措施（一种基于互联网的癌症临床试验匹配工具）的可接受性、疗效初步估计值和可行性。本研究还将考察旨在满足更广泛患者群体语言和读写需求的试验库网站在多大程度上影响患者发起与医生关于参与临床试验的对话。
这是一项非随机单臂试点研究的研究方案。这是一种混合方法研究设计，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库干预措施的体验。本研究将考察：（1）可接受性，作为参与者对该干预措施满意度的衡量指标；（2）疗效初步衡量指标，作为电子病历中有记录的临床试验讨论参与者比例的衡量指标；（3）干预措施的可行性，作为临床就诊时长的衡量指标。
为试验库干预措施设计提供指导的原则旨在适用于多种疾病背景下的临床试验。从根本上讲，该干预措施的设计旨在满足代表性不足患者群体的语言、读写和技术需求。本研究将在试验库干预措施的多中心随机临床试验之前收集重要的初步数据。
本研究已获得加利福尼亚大学旧金山分校人类受试者研究委员会的机构批准。
