Working Through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER²S)
ACT WONDER²S
2 other identifiers
interventional
7,649
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Sep 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedStudy Start
First participant enrolled
September 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
April 1, 2026
March 1, 2026
2 years
August 15, 2024
March 31, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Enrollment of Black and Hispanic Patients to NCI-sponsored cancer treatment clinical trials
Intervention impact on enrollment rates 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.
2 years
Secondary Outcomes (5)
Referral of Black and Hispanic Patients to Moffitt Cancer Center
2 Years
Community residents in the intervention CAPZ
2 years
Community physicians in the intervention CAPZ
2 years
Cancer Center CRC
2 years
Cancer Center Physician
2 years
Study Arms (6)
Catchment Area Priority Zone (CAPZ) Intervention - Community Residents and Moffitt Patients
EXPERIMENTALStudy 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.
Catchment Area Priority Zone (CAPZ) Control - Community Residents and Moffitt Patients
ACTIVE COMPARATORStudy 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.
Catchment Area Priority Zone (CAPZ) Intervention - Community Physicians
EXPERIMENTALStudy 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.
Catchment Area Priority Zone (CAPZ) Control- Community Physicians
ACTIVE COMPARATORStudy 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.
Cancer Center Clinical Research Coordinators (CRCs)
EXPERIMENTALCRCs 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.
Cancer Center Physicians
EXPERIMENTALPhysicians 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.
Interventions
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.
A digital tool to help facilitate rapid referral of patients to clinical trial opportunities at Moffitt.
Electronic/paper newsletters to highlight open trials at Moffitt that will be distributed by email/mail.
A one-hour educational module will cover information on implicit bias to support the recruitment of diverse patients.
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.
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.
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.
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.
Including CHOICES DA, a web-based tool to improve multiple aspects of decision-making related to participation in cancer clinical trials.
Control group with no intervention.
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.
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Vadaparampil, PhD
Moffitt Cancer Center
- PRINCIPAL INVESTIGATOR
Dana Rollison, PhD
Moffitt Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2024
First Posted
August 19, 2024
Study Start
September 18, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
April 1, 2026
Record last verified: 2026-03