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

NCT ID: NCT06560398

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

7649 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-18

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Clinical Trial Education Sessions (Community Residents Only)

Intervention Type 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)

Intervention Type 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)

Intervention Type BEHAVIORAL

Including CHOICES DA, a web-based tool to improve multiple aspects of decision-making related to participation in cancer clinical trials.

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.

Group Type ACTIVE_COMPARATOR

No Intervention

Intervention Type OTHER

Control group with no intervention.

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.

Group Type EXPERIMENTAL

Continuing Medical Education Events (CME)

Intervention Type 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

Intervention Type BEHAVIORAL

A digital tool to help facilitate rapid referral of patients to clinical trial opportunities at Moffitt.

Clinical Trial Newsletters

Intervention Type BEHAVIORAL

Electronic/paper newsletters to highlight open trials at Moffitt that will be distributed by email/mail.

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.

Group Type ACTIVE_COMPARATOR

No Intervention

Intervention Type OTHER

Control group with no intervention.

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.

Group Type EXPERIMENTAL

Trial Connect Portal

Intervention Type BEHAVIORAL

A digital tool to help facilitate rapid referral of patients to clinical trial opportunities at Moffitt.

Implicit Bias Training

Intervention Type BEHAVIORAL

A one-hour educational module will cover information on implicit bias to support the recruitment of diverse patients.

Recruitment Dashboard

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Trial Connect Portal

Intervention Type BEHAVIORAL

A digital tool to help facilitate rapid referral of patients to clinical trial opportunities at Moffitt.

Implicit Bias Training

Intervention Type BEHAVIORAL

A one-hour educational module will cover information on implicit bias to support the recruitment of diverse patients.

Recruitment Dashboard

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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Continuing Medical Education Events (CME)

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.

Intervention Type BEHAVIORAL

Trial Connect Portal

A digital tool to help facilitate rapid referral of patients to clinical trial opportunities at Moffitt.

Intervention Type BEHAVIORAL

Clinical Trial Newsletters

Electronic/paper newsletters to highlight open trials at Moffitt that will be distributed by email/mail.

Intervention Type BEHAVIORAL

Implicit Bias Training

A one-hour educational module will cover information on implicit bias to support the recruitment of diverse patients.

Intervention Type BEHAVIORAL

Recruitment Dashboard

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.

Intervention Type BEHAVIORAL

Portfolio Profiler

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.

Intervention Type BEHAVIORAL

Eligibility Calculator

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.

Intervention Type BEHAVIORAL

Clinical Trial Education Sessions (Community Residents Only)

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.

Intervention Type BEHAVIORAL

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

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.

Intervention Type BEHAVIORAL

New Patient Information (Moffitt Patients Only)

Including CHOICES DA, a web-based tool to improve multiple aspects of decision-making related to participation in cancer clinical trials.

Intervention Type BEHAVIORAL

No Intervention

Control group with no intervention.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Vadaparampil, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Dana Rollison, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rossybelle Amorrortu, MPH

Role: CONTACT

813-745-4007

Lindsay Fuzzell, PhD

Role: CONTACT

Facility Contacts

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Rossybelle Amorrortu, MPH

Role: primary

813-745-4007

Lindsay Fuzzell, PhD

Role: backup

Related Links

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https://www.moffitt.org/clinical-trials-research/clinical-trials/

Moffitt Cancer Center Clinical Trials website

Other Identifiers

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U01CA274971-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-22140

Identifier Type: -

Identifier Source: org_study_id

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