H. Lee Moffitt Cancer Center and Research Institute
The purpose of the study is to refine, finalize, implement, and evaluate a multi-level intervention aimed at increasing enrollment of Black and Hispanic patients to National Cancer Institute (NCI)-sponsored therapeutic clinic trials at Moffitt Cancer Center.
Cancer
Continuing Medical Education Events (CME)
Trial Connect Portal
Clinical Trial Newsletters
Implicit Bias Training
Recruitment Dashboard
Portfolio Profiler
Eligibility Calculator
Clinical Trial Education Sessions (Community Residents Only)
ACT WONDER²S Phone-line/Email (Community Residents and Moffitt Patients)
New Patient Information (Moffitt Patients Only)
No Intervention
NA
A stratified cluster randomized design will be used to assess the impact of the Advancing Clinical Trials: Working through Outreach, Navigation, and Digitally Enabled Referral and Recruitment Strategies (ACT WONDER²S) multi-level intervention on increasing referral and enrollment to NCI-sponsored therapeutic clinical trials among Black and Hispanic patients. Geospatial analytics were used to identify clusters of census tracts within the Moffitt catchment area ("priority zones") with high Black and Hispanic populations for intervention deployment. Priority zones were then matched on population characteristics and randomized to receive the intervention (n=7) or to serve as controls (n=7). External target populations within the Catchment Area Priority Zone (CAPZ) include community residents and community physicians, while internal target populations within Moffitt Cancer Center (Moffitt) include physicians, clinical research coordinators (CRCs), and patients. The outreach and education intervention components will be facilitated by community health educators (CHEs) targeting community residents (Clinical Trial Education module and CHE support through the ACT WONDER²S Phone-line/Email), community physicians (Continuing Medical Education sessions including implicit bias training), patients at Moffitt (CHE support) and cancer center physicians/CRCs (an implicit bias training). Digitally enabled decision support tools will be developed and deployed to the CHE's (a data-empowered interactive map for outreach planning \[Precision Engagement Tool\]), community physicians (Clinical Trial Newsletters), patients at Moffitt (a clinical trial decision aid \[CHOICES DA\]), and cancer center physicians/CRCs (a recruitment dashboard to monitor clinical trial accrual rates, a clinical trial portfolio profiler, and a tool to assess the impact of clinical trial inclusion/exclusion criteria on eligibility across patient populations defined by age, race, and ethnicity \[Eligibility Criteria Calculator\]). In addition, an online portal (called the Trial Connect Portal) will be developed to connect community-based referring physicians to information about MCC trials and to facilitate their communication with cancer center physicians and CRCs. The primary outcome, enrollment to clinical trials, will be measured by comparing the percentage of Moffitt patients enrolled on NCI-supported treatment trials who are Black or Hispanic between intervention priority zones and the control priority zones. The secondary outcome, referral to Moffitt, will be measured by comparing the percentage of patients referred to Moffitt who are Black or Hispanic between the intervention priority zones and the control priority zones.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 7649 participants |
| Masking : | NONE |
| Primary Purpose : | HEALTH_SERVICES_RESEARCH |
| Official Title : | Working Through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER²S) |
| Actual Study Start Date : | 2024-09-18 |
| Estimated Primary Completion Date : | 2026-09-01 |
| Estimated Study Completion Date : | 2026-09-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Moffitt Cancer Center
Tampa, florida, United States, 33612