RecruitingNot ApplicableNCT06560398

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


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

7,649 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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).

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Interventions

BEHAVIORALContinuing 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.

BEHAVIORALTrial Connect Portal

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

BEHAVIORALClinical Trial Newsletters

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

BEHAVIORALImplicit Bias Training

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

BEHAVIORALRecruitment 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.

BEHAVIORALPortfolio 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.

BEHAVIORALEligibility 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.

BEHAVIORALClinical 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.

BEHAVIORALACT 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.

BEHAVIORALNew 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.

OTHERNo Intervention

Control group with no intervention.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT06560398


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