Recruiting

Observational Study

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT06560398

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Continuing Medical Education Events (CME)

Trial Connect Portal

Clinical Trial Newsletters

Implicit Bias Training

Recruitment Dashboard

Study Details

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.

Conditions

Cancer

Study ID

NCT06560398

Start date

Sep 18, 2024

Status verified date

Sep, 2026

Completion date

Sep 16, 2026

Anticipated

Primary completion date

Sep 16, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

7649 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

Trial Connect Portal

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

Clinical Trial Newsletters

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

Implicit Bias Training

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

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.

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.

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.

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.

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.

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.

No Intervention

Control group with no intervention.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Rossybelle Amorrortu, MPH

813-745-4007Rossybelle.Amorrortu@moffitt.org

Lindsay Fuzzell, PhD

Lindsay.Fuzzell@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Rossybelle Amorrortu, MPH

813-745-4007Rossybelle.Amorrortu@moffitt.org

Lindsay Fuzzell, PhD

Linsday.Fuzzell@moffitt.org

Principal Investigator:

Susan Vadaparampil, PhD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-09-03.