Working Through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER²S) (ACT WONDER²S)
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Clinical Trial Education Sessions (Community Residents Only)
- Behavioral: ACT WONDER²S Phone-line/Email (Community Residents and Moffitt Patients)
- Behavioral: New Patient Information (Moffitt Patients Only)
- Other: No Intervention
- Behavioral: Continuing Medical Education Events (CME)
- Behavioral: Trial Connect Portal
- Behavioral: Clinical Trial Newsletters
- Behavioral: Implicit Bias Training
- Behavioral: Recruitment Dashboard
- Behavioral: Portfolio Profiler
- Behavioral: Eligibility Calculator
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rossybelle Amorrortu, MPH
- Phone Number: 813-745-4007
- Email: Rossybelle.Amorrortu@moffitt.org
Study Contact Backup
- Name: Lindsay Fuzzell, PhD
- Email: Lindsay.Fuzzell@moffitt.org
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- Recruiting
- Moffitt Cancer Center
-
Sub-Investigator:
- Kedar Kirtane, MD
-
Sub-Investigator:
- Kea Turner, PhD
-
Sub-Investigator:
- Hatem Soliman, MD
-
Sub-Investigator:
- Margaret Byrne, PhD
-
Principal Investigator:
- Susan Vadaparampil, PhD
-
Contact:
- Rossybelle Amorrortu, MPH
- Phone Number: 813-745-4007
- Email: Rossybelle.Amorrortu@moffitt.org
-
Contact:
- Lindsay Fuzzell, PhD
- Email: Linsday.Fuzzell@moffitt.org
-
Principal Investigator:
- Dana Rollison, PhD
-
Sub-Investigator:
- Cathy Meade, PhD
-
Sub-Investigator:
- Clement Gwede, PhD
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Sub-Investigator:
- Steven Eschrich, PhD
-
Sub-Investigator:
- Vivien Yin, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
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.
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.
Including CHOICES DA, a web-based tool to improve multiple aspects of decision-making related to participation in cancer clinical trials.
|
|
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.
|
Control group with no intervention.
|
|
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.
|
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.
|
|
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.
|
Control group with no intervention.
|
|
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.
|
A digital tool to help facilitate rapid referral of patients to clinical trial opportunities at Moffitt.
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.
|
|
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.
|
A digital tool to help facilitate rapid referral of patients to clinical trial opportunities at Moffitt.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enrollment of Black and Hispanic Patients to NCI-sponsored cancer treatment clinical trials
Time Frame: 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Referral of Black and Hispanic Patients to Moffitt Cancer Center
Time Frame: 2 Years
|
Intervention impact on referral rates 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.
|
2 Years
|
|
Community residents in the intervention CAPZ
Time Frame: 2 years
|
The number of community residents that attend a CT educational session.
|
2 years
|
|
Community physicians in the intervention CAPZ
Time Frame: 2 years
|
The number of physicians that attend a CME event.
|
2 years
|
|
Cancer Center CRC
Time Frame: 2 years
|
The number of CRCs that used at least one of the CT digital tools.
|
2 years
|
|
Cancer Center Physician
Time Frame: 2 years
|
The number of MCC physicians that used at least one of the CT digital tools.
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Susan Vadaparampil, PhD, Moffitt Cancer Center
- Principal Investigator: Dana Rollison, PhD, Moffitt Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-22140
- U01CA274971-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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