Background/objectives: Racial and ethnic minority patients are underrepresented in cancer clinical trials (CCTs) and multilevel strategies are required to increase participation. This study describes barriers and facilitators to minority CCT participation alongside feedback on a multilevel intervention (MLI) designed to reduce participation barriers, as posited by the socioecological model (SEM). Methods: Interviews with Moffitt Cancer Center (MCC) physicians, community physicians, patients with cancer, community residents, and clinical research coordinators (CRCs) were conducted from June 2023–February 2024. Verbal responses were analyzed using thematic analysis and categorized into SEM levels. Mean helpfulness scores rating interventions (from 1 (not helpful) to 5 (very helpful)) were summarized. Results: Approximately 50 interviews were completed. Thematic findings confirmed CCT referral and enrollment barriers across all SEM levels. At the community level, MCC patients and community residents felt that community health educators can improve patient experiences and suggested they connect patients to social/financial resources, assist with patient registration, and provide CCT education. While physicians and CRCs reacted positively to all institutional-level tools, the highest scored tool simultaneously addressed CCT referral and enrollment at the institution (e.g., trial identification/referrals) and interpersonal level (communication platform for community and MCC physicians) (mean = 4.27). At the intrapersonal level, patients were enthusiastic about a digital CCT decision aid (mean = 4.53) and suggested its integration into MCC’s patient portal. Conclusions: Results underscore the value of conducting formative research to tailor interventions to target population needs. Our approach can be leveraged by future researchers seeking to evaluate MLIs addressing additional CCT challenges or broader health topics.
背景/目的：少数种族和民族患者在癌症临床试验中的代表性不足，需要采取多层次策略以提高其参与度。本研究基于社会生态学模型，旨在描述少数群体参与癌症临床试验的障碍与促进因素，并对一项旨在降低参与障碍的多层次干预措施收集反馈意见。方法：于2023年6月至2024年2月期间，对莫菲特癌症中心的医生、社区医生、癌症患者、社区居民及临床研究协调员进行访谈。采用主题分析法对口头回答内容进行分析，并按社会生态学模型层次进行分类。同时汇总了干预措施的有益性评分平均值（评分范围1分（无帮助）至5分（非常有帮助））。结果：共完成约50次访谈。主题分析结果证实了癌症临床试验转诊与入组障碍存在于社会生态学模型的所有层面。在社区层面，莫菲特癌症中心患者和社区居民认为社区健康教育者能改善患者体验，并建议其帮助患者对接社会/经济资源、协助患者登记注册以及提供癌症临床试验教育。尽管医生和临床研究协调员对所有机构层面工具均持积极态度，但评分最高的工具能同时解决机构层面（如试验识别/转诊）和人际层面（社区与莫菲特癌症中心医生的沟通平台）的癌症临床试验转诊与入组问题（平均分=4.27）。在个人层面，患者对数字化癌症临床试验决策辅助工具表现出高度热情（平均分=4.53），并建议将其整合至莫菲特癌症中心患者门户系统中。结论：研究结果凸显了开展形成性研究对针对目标人群需求定制干预措施的重要价值。未来研究者可借鉴本方法，评估针对其他癌症临床试验挑战或更广泛健康议题的多层次干预措施。
肿瘤(癌症)患者之家