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

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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.