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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06560398
Status
Recruiting
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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Continuing Medical Education Events (CME) — BEHAVIORAL
    An engaging 1-hour informational session focusing on topic areas such as implicit bias and emerging evidence from recent cancer clinical trials with CME credit or American Board of Internal Medicine (ABIM) Maintenance of Certification (MOC) points available.
  • Trial Connect Portal — BEHAVIORAL
    A digital tool to help facilitate rapid referral of patients to clinical trial opportunities at Moffitt.
  • Clinical Trial Newsletters — BEHAVIORAL
    Electronic/paper newsletters to highlight open trials at Moffitt that will be distributed by email/mail.
  • Implicit Bias Training — BEHAVIORAL
    A one-hour educational module will cover information on implicit bias to support the recruitment of diverse patients.
  • Recruitment Dashboard — BEHAVIORAL
    A dynamic dashboard depicting the number of patients recruited to clinical trials by gender, race, ethnicity, age, cancer type, residence in the catchment area, and other key clinical characteristics.
  • Portfolio Profiler — BEHAVIORAL
    An interactive dashboard to allow cancer center physicians easily identify gaps in the current clinical trial portfolio that may be contributing to racial/ethnic disparities in trial enrollment.
  • Eligibility Calculator — BEHAVIORAL
    A digital calculator that will allow for assessment of the potential impact of clinical trial eligibility criteria (e.g., comorbidities, age, lab values) that may disproportionately exclude patients who are Black and Hispanic prior to submission of clinical trial protocols to the Scientific Review Committee.
  • Clinical Trial Education Sessions (Community Residents Only) — BEHAVIORAL
    An engaging 1-hour educational session delivered by a community health educator that includes basic information about clinical trials, their importance, myths, need for diversity in the trials process, and resources for finding more information about clinical trials.
  • ACT WONDER²S Phone-line/Email (Community Residents and Moffitt Patients) — BEHAVIORAL
    A study team member will be available for questions via a dedicated phone-line and email for community residents and Moffitt patients with a return contact within 24-hours.
  • New Patient Information (Moffitt Patients Only) — BEHAVIORAL
    Including CHOICES DA, a web-based tool to improve multiple aspects of decision-making related to participation in cancer clinical trials.
  • No Intervention — OTHER
    Control group with no intervention.

Study Details

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.

Key Dates

Start date
Sep 18, 2024
Status verified
Mar 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
7,649 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Catchment Area Priority Zone (CAPZ) Intervention - Community Residents and Moffitt Patients
    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.
  • Active Comparator: Catchment Area Priority Zone (CAPZ) Control - Community Residents and Moffitt Patients
    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.
  • Experimental: Catchment Area Priority Zone (CAPZ) Intervention - Community Physicians
    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.
  • Active Comparator: Catchment Area Priority Zone (CAPZ) Control- Community Physicians
    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.
  • Experimental: Cancer Center Clinical Research Coordinators (CRCs)
    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.
  • Experimental: Cancer Center Physicians
    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.

Primary Outcome Measure

Enrollment of Black and Hispanic Patients to NCI-sponsored cancer treatment clinical trials [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Rossybelle Amorrortu, MPH
[email protected]
813-745-4007
Lindsay Fuzzell, PhD
[email protected]
Susan Vadaparampil, PhD (PRINCIPAL_INVESTIGATOR)
Dana Rollison, PhD (PRINCIPAL_INVESTIGATOR)
Kea Turner, PhD (SUB_INVESTIGATOR)
Kedar Kirtane, MD (SUB_INVESTIGATOR)
Hatem Soliman, MD (SUB_INVESTIGATOR)
Margaret Byrne, PhD (SUB_INVESTIGATOR)
Cathy Meade, PhD (SUB_INVESTIGATOR)
Clement Gwede, PhD (SUB_INVESTIGATOR)
Steven Eschrich, PhD (SUB_INVESTIGATOR)
Vivien Yin, PhD (SUB_INVESTIGATOR)

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