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

Limited participation in therapeutic clinical trials perpetuates significant variations in cancer care and health outcomes. Patients not enrolled in clinical trials benefit less often from state-of-the-art care, and the lack of trial participants limits the generalizability of trial findings, potentially limiting the clinical use of new treatments. The vast majority of patients receive their care in community settings with community physicians. Increasing 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 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 populations who have suboptimal cancer health outcomes, research to address 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 (areas with groups experiencing suboptimal cancer outcomes) within the catchment area of Moffitt Cancer Center. Our primary outcome is enrollment to NCI-sponsored therapeutic clinical trials among 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 patient referral and enrollment on NCI-sponsored cancer treatment trials using a stratified cluster randomized 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.