Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)

Recruiting

• Conditions: Leukemia; Blood Cancer
• Interventions: Other: DIVERSE Review Process

• Registration Number: NCT06469307
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

The purpose of this research study is to enhance inclusion and diversity in clinical trial enrollment by training participants to perform and provide feedback through a community-based protocol review process, called DIVERSE.

Detailed Description

This research study aims to pilot a protocol review process, called DIVERSE, assessing its feasibility, acceptability, and preliminary efficacy to enhance inclusion and diversity in clinical trial enrollment. Patients and community participants will complete specialized training and provide feedback on clinical trials in development through the DIVERSE process; they will also provide feedback on the process itself. Investigator participants will request review and provide feedback on the DIVERSE process. The study is based on community-based participatory research.

Participation in this research is expected to last about 18 months. It is expected that about 20 patient and community participants and 20 investigators will participate in this research study. The National Cancer Institute and American Society of Clinical Oncology are providing funding for this research study.

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-21
• Study Start: 2025-01-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-19
• Primary Completion: 2026-07-01
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 18 or older
• English speaking
• Ability to understand and willingness to provide oral consent
• DFCI patient who are in remission from a blood cancer >1 year will be preferred.

CAB Participant

Exclusion Criteria

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers <18 years old)
• Prisoners.
• Unwilling/unable to agree to maintaining the confidentiality of reviews and clinical trial materials, as outlined in Section 9.1
• Note 1: Patients and non-patient community members who are pregnant are eligible. This is a non-interventional study that meets the definition of minimal risk and poses no greater risk to pregnant individuals or fetuses. Pregnancy status will not be assessed.
• Note 2: English fluency is necessary as protocols being reviewed are written in English and cannot be feasibly translated to other languages within the time period necessary to complete timely reviews.

Investigator Participant Inclusion Criteria:

• Age 18 older
• English Speaking
• Site or Principal investigator
• Not a member of the research team

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DIVERSE Investigators	DIVERSE Review Process	Enrolled investigator participants will complete: * Brief Feedback Survey * Request DIVERSE reviews and complete request form * Acceptability of Intervention Measure questionnaire * Semi-structured exit interview and/or focus group with study staff to provide feedback
DIVERSE Community Advisory Board (CAB)	DIVERSE Review Process	Enrolled participants will complete: * Confidentiality agreement and demographic questionnaire * Online training and in-person or remote training with study team * Timely DIVERSE review of protocols * Audio recorded meeting (in-person, remote, or via phone call) with study team to present review findings * Semi-structured exit interview and/or focus group with study staff to provide feedback

Primary Outcome Measures

Name	Time	Method
Protocol Review Completion Rate	18 months	Feasibility is defined as the proportion of eligible protocols that have completed the DIVERSE review process. The target is a review completion of ≥ 60% of eligible protocols.
Protocol Review Completion Rate Within 35 Days	18 months	Feasibility is defined as the proportion of protocols that have completed the DIVERSE review process within 35 days of request. The goal is to have ≥ to 70% of reviews completed within 35 days.
Proportion of Acceptability of Intervention Measure (AIM) Scores of 10 or Greater	18 months	Acceptability is defined as the proportion of AIM scores provided by investigators after protocols have been assessed by the DIVERSE review process with ≥ 60% of AIM scores resulting as ≥10 on a scale of 0 - 20, where scores of 10 or above are considered "acceptable" or greater. The AIM is a 4-item, 5-point Likert scale-based measure.

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States