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

摘要 在治疗性临床试验中，种族/少数族裔的有限参与使癌症护理方面的差异永久化。 不仅种族/少数民族患者通过临床提供的最先进的护理机会有限 审判，但少数族裔参与者人数较少，降低了结论的概括性，因此 限制新疗法的临床应用。绝大多数种族/民族少数群体在 与社区医生的社区环境。年增加的种族/少数民族转介和入学人数 临床试验需要考虑多层次的影响。社区病人，社区医生， 癌症中心的医生在推荐和招募少数民族参加临床试验时都面临着障碍。 包括：知识、态度、信任和物流。为了应对这些挑战，我们有 设计的先进临床试验：通过导航和数字启用的转诊和 招聘战略(ACT WONDER2S)，由社区长期伙伴关系推动，以解决 医疗服务不足人群的需求，研究以解决试验所产生的种族/少数民族问题， 以及一种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/或通过数字技术提供的策略 社区患者(教育、患者门户、CHE支持)、社区医生的方法 (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、试用连接门户、CHE支持、招聘仪表板)。第二幕将是 在莫菲特癌症中心集水区内确定的优先区域实施，这些区域具有更高的 黑人和/或西班牙裔人口中的癌症负担。我们的主要结果是少数族裔入学NCI- 两年期间在黑人和西班牙裔癌症患者中赞助的治疗临床试验 在干预之后。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 目的：1)通过开展访谈，细化和最终确定ACT WONDER2S干预措施组成部分 评估对CHE主导和数字驱动的干预措施的设计和功能的偏好；2) 实施和评估ACT WONDER2S对少数民族患者转诊和登记的影响 关于NCI赞助的癌症治疗试验，使用历史对照设计；3)评估实施结果 并确定实施WONDER2S的障碍和促进者。这种创新的干预在其多层次上是独一无二的 利用社区患者、社区医生和癌症患者可访问的数字工具的系统方法 中心医生，再加上CHS对每个利益相关者的支持。我们对地理空间的使用 识别优先区域的分析是一个独特的优势，以及将整合 学员验证、以用户为中心的设计和实施科学，以完善干预组件和 让我们的行动取得成功。

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.