Advancing Clinical Trials: Working through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDERS)

摘要 少数种族/族裔在治疗性临床试验中的参与有限，使癌症护理的差异长期存在。 不仅少数种族/民族患者获得通过临床医疗机构提供的最先进护理的机会有限， 试验，但少数种族/少数民族参与者的数量减少了调查结果的普遍性， 限制了新疗法的临床应用。绝大多数少数种族/族裔得到他们的照顾， 与社区医生一起进行社区设置。增加少数种族/族裔的转诊和入学率 临床试验需要考虑多层次的影响。社区病人，社区医生， 和癌症中心的医生都面临着转诊和招募少数种族/民族参加临床试验的障碍 包括：知识、态度、信任和后勤。为了应对这些挑战，我们 推进临床试验：通过导航和数字化转诊进行外展， 招聘战略（ACT WONDER 2S），由长期的社区合作伙伴关系推动，以解决 医疗服务不足人群的需求，解决试验中种族/族裔少数的研究， 以及高度集成的数字驱动方法，用于精确的癌症护理和临床试验。我们的多层次 干预措施包括通过社区健康教育者（CHE）和/或通过数字 社区患者的方法（教育、患者门户网站、CHE支持）、社区医生 （教育、试验连接门户、癌症中心医生参与和CHE支持）和癌症中心 医生（教育、试验连接门户、CHE支持、招聘仪表板）。ACT WONDER 2S将在 在莫菲特癌症中心集水区内确定的优先区域实施， 黑人和/或西班牙裔人群的癌症负担。我们的主要结果是少数民族进入国家癌症研究所- 在黑人和西班牙裔癌症患者中进行为期两年的赞助治疗性临床试验 干预后。在基于学习者验证和以用户为中心的设计的三阶段方法中，我们 目标是：1）通过进行访谈，完善并最终确定ACT WONDER 2S干预组件 评估对由社区教育主管部门领导和数字化驱动的干预措施的设计和功能的偏好; 2） 实施并评估ACT WONDER 2S对种族/少数民族患者转诊和入组的影响 使用历史对照设计的NCI申办的癌症治疗试验; 3）评估实施结果 并确定ACT WONDER 2S的障碍和促进因素。这种创新的干预措施在其多层次方面是独一无二的 系统方法，利用社区患者、社区医生和癌症患者可使用的数字化工具 中心医生，这是再加上支持从CHE为每个这些利益相关者。我们对地理空间的使用 确定优先区域的分析是一个独特的优势，沿着方法创新， 学习者验证、以用户为中心的设计和实施科学，以完善干预组件， 让ACT WONDER 2S取得成功。

Abstract Limited participation of racial/ethnic minorities in therapeutic clinical trials perpetuates cancer care disparities. Not only do racial/ethnic minority patients have limited access to state-of-the art care offered through a clinical trial, but the small numbers of racial/ethnic minority participants reduces the generalizability of findings, thereby limiting the clinical use of new treatments. The vast majority of racial/ethnic minorities receive their care in community settings with community physicians. Increasing racial/ethnic minority referral and enrollment in clinical trials requires consideration of multiple levels of influence. Community patients, community physicians, and cancer center physicians all face barriers to referral and enrollment of racial/ethnic minorities to clinical trials including: knowledge, attitudes, trust, and logistics. To address these challenges, we have designed Advancing Clinical Trials: Working through Outreach via Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER2S), driven by longstanding community partnerships to address the needs of medically underserved populations, research to address racial/ethnic minority accrual to trials, and a highly integrated digitally driven approach to precision cancer care and clinical trials. Our multilevel intervention includes strategies that are delivered via a community health educator (CHE) and/or through digital approaches for the community patient (education, patient portal, CHE support), community physician (education, trial connect portal, cancer center physician engagement, and CHE support), and cancer center physician (education, trial connect portal, CHE support, recruitment dashboard). ACT WONDER2S will be implemented in identified priority zones within the catchment area of Moffitt Cancer Center that have a higher cancer burden among Black and/or Hispanic populations. Our primary outcome is minority enrollment to NCI- sponsored therapeutic clinical trials among Black and Hispanic patients with cancer in the two-year period following intervention. In a three-phase approach based on learner verification and user-centered design, we aim to: 1) Refine and finalize the ACT WONDER2S intervention components by conducting interviews assessing preferences for the design and functionality of the CHE-led and digitally driven interventions; 2) Implement and evaluate the impact of ACT WONDER2S on racial/ethnic minority patient referral and enrollment on NCI-sponsored cancer treatment trials using a historical control design; 3) Assess implementation outcomes and identify barriers and facilitators to ACT WONDER2S. This innovative intervention is unique in its multilevel systems approach that utilizes digital tools accessible to community patients, community physicians, and cancer center physicians, which is coupled with support from CHEs for each of these stakeholders. Our use of geospatial analytics to identify priority zones is a unique strength, along with methodological innovations that will integrate learner verification, user centered design, and implementation science to refine intervention components and make ACT WONDER2S a success.