Working Through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER²S)

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: Cancer

Treatments: Behavioral: Portfolio Profiler; Behavioral: Implicit Bias Training; Behavioral: Eligibility Calculator; Behavioral: Trial Connect Portal; Behavioral: ACT WONDER²S Phone-line/Email (Community Residents and Moffitt Patients); Behavioral: Continuing Medical Education Events (CME); Other: No Intervention; Behavioral: Recruitment Dashboard; Behavioral: Clinical Trial Newsletters; Behavioral: New Patient Information (Moffitt Patients Only); Behavioral: Clinical Trial Education Sessions (Community Residents Only)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06560398

MCC-22140

U01CA274971-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 7,649 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Community residents: Community residents may engage with various intervention components deployed in the intervention priority zones.
• Community Physicians: may engage with various intervention components deployed in the intervention priority zones if they 1) practice medicine in one of the geographic priority zones.
• Cancer Center Physicians: may engage with various intervention components if they 1) practice medicine at Moffitt.
• Clinical Research Coordinators (CRC): may engage with various intervention components if they 1) work as a CRC at Moffitt and 2) coordinate/pre-screen patients for at least 1 therapeutic clinical trial at Moffitt.
• Cancer Center Patients: may engage with various intervention components if they have an address that maps to an intervention priority zone and 2) are newly registered patients or new existing patients (NEPs).

Exclusion criteria

• Community residents, Community Physicians, Cancer Center Physicians, Clinical Research Coordinators, and Moffitt patients who do not meet the inclusion criteria.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,649 participants in 6 patient groups

Catchment Area Priority Zone (CAPZ) Intervention - Community Residents and Moffitt Patients

Experimental group

Description:

Study interventions will be deployed in geographically defined intervention priority zones including Clinical Trial Education sessions and the ACT WONDER²S Phone-line/Email. Community residents in these zones may be exposed to these interventions. Residents who are also new patients to Moffitt may be exposed to the CHOICES DA website once they are registered at Moffitt.

Treatment:

Behavioral: New Patient Information (Moffitt Patients Only)

Behavioral: Clinical Trial Education Sessions (Community Residents Only)

Behavioral: ACT WONDER²S Phone-line/Email (Community Residents and Moffitt Patients)

Catchment Area Priority Zone (CAPZ) Control - Community Residents and Moffitt Patients

Active Comparator group

Description:

Study interventions will not be deployed in the control priority zones. Community residents in these zones are unlikely to be exposed to any of the study interventions.

Treatment:

Other: No Intervention

Catchment Area Priority Zone (CAPZ) Intervention - Community Physicians

Experimental group

Description:

Study interventions will be deployed in geographically defined intervention priority zones including Continuing Medical Education events, the Trial Connect Portal, and Clinical Trial Newsletters. Community physicians in these zones may be exposed to these interventions.

Treatment:

Behavioral: Clinical Trial Newsletters

Behavioral: Continuing Medical Education Events (CME)

Behavioral: Trial Connect Portal

Catchment Area Priority Zone (CAPZ) Control- Community Physicians

Active Comparator group

Description:

Study interventions will not be deployed in the control priority zones. Community physicians in these zones are unlikely to be exposed to any of the study interventions.

Treatment:

Other: No Intervention

Cancer Center Clinical Research Coordinators (CRCs)

Experimental group

Description:

CRCs that work on therapeutic clinical trials at Moffitt will have access to the implicit bias educational module and digital tools to monitor and enhance minority recruitment, including the Trial Connect Portal and Recruitment Dashboard.

Treatment:

Behavioral: Recruitment Dashboard

Behavioral: Trial Connect Portal

Behavioral: Implicit Bias Training

Cancer Center Physicians

Experimental group

Description:

Physicians at Moffitt will have access to the implicit bias educational module and to digital tools to monitor and enhance minority recruitment, including the Trial Connect Portal, Recruitment Dashboard, Portfolio Profiler, and the Eligibility Criteria Calculator.

Treatment:

Behavioral: Recruitment Dashboard

Behavioral: Eligibility Calculator

Behavioral: Trial Connect Portal

Behavioral: Portfolio Profiler

Behavioral: Implicit Bias Training