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

NCT ID: NCT06469307

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-09

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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Blood Cancer Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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DIVERSE Community Advisory Board (CAB)

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

Group Type OTHER

DIVERSE Review Process

Intervention Type OTHER

A participant and community-based review system for clinical research protocols that elicits and collects feedback on investigator-initiated protocol reviews.

DIVERSE Investigators

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

Group Type OTHER

DIVERSE Review Process

Intervention Type OTHER

A participant and community-based review system for clinical research protocols that elicits and collects feedback on investigator-initiated protocol reviews.

Interventions

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DIVERSE Review Process

A participant and community-based review system for clinical research protocols that elicits and collects feedback on investigator-initiated protocol reviews.

Intervention Type OTHER

Other Intervention Names

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DIVERSE

Eligibility Criteria

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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.


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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

American Society of Clinical Oncology

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Andrew Hantel, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Hantel, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrew Hantel, MD

Role: CONTACT

617-582-9394

Thomas Walsh, MPH

Role: CONTACT

857-215-2365

Facility Contacts

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Andrew Hantel, MD

Role: primary

617-582-9394

Other Identifiers

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K08CA273043

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-177

Identifier Type: -

Identifier Source: org_study_id

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