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

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Blood Cancer; Leukemia

Treatments: Other: DIVERSE Review Process

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06469307

24-177

K08CA273043 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

CAB Participant 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

DIVERSE Community Advisory Board (CAB)

Other group

Description:

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

Treatment:

Other: DIVERSE Review Process

DIVERSE Investigators

Other group

Description:

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

Treatment:

Other: DIVERSE Review Process