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NCT Number: NCT06469307

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

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.

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Key information

Conditions

Blood Cancer Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Andrew Hantel, MD

CONTACT

[email protected]

617-582-9394

Andrew Hantel, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DIVERSE Review Process

Other

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

Other names: DIVERSE

Primary outcomes

  1. Protocol Review Completion Rate

    Time frame: 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.

  2. Protocol Review Completion Rate Within 35 Days

    Time frame: 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.

  3. Proportion of Acceptability of Intervention Measure (AIM) Scores of 10 or Greater

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Hantel, MD

CONTACT

[email protected]

617-582-9394

Oldy S Bejarano, MPH

CONTACT

[email protected]

857-215-2365

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • American Society of Clinical Oncology
  • National Cancer Institute (NCI)

Registry information

Acronym: DIVERSE

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 21, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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