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

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Trial Connect Portal

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

BEHAVIORAL

Clinical Trial Newsletters

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

BEHAVIORAL

Implicit Bias Training

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

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.

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.

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.

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.

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.

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.

OTHER

No Intervention

Control group with no intervention.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• H. Lee Moffitt Cancer Center and Research Institute

  lead OTHER

Principal Investigators

• Susan Vadaparampil, PhD · Moffitt Cancer Center

• Dana Rollison, PhD · Moffitt Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-18

Primary Completion

2026-09-01

Completion

2026-09-01

Countries

• United States

Study Locations