Recruiting

Observational Study

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06469307

Conditions

Blood Cancer

Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

DIVERSE Review Process

Study Details

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.

Conditions

Blood Cancer

Leukemia

Study ID

NCT06469307

Start date

Dec 9, 2024

Status verified date

Jul, 2026

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: 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

other: 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

Interventions

DIVERSE Review Process

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

Primary outcome measure

  • Protocol Review Completion Rate [ Time Frame: 18 months ]
  • Protocol Review Completion Rate Within 35 Days [ Time Frame: 18 months ]
  • Proportion of Acceptability of Intervention Measure (AIM) Scores of 10 or Greater [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Andrew Hantel, MD

617-582-9394Andrew_Hantel@dfci.harvard.edu

Oldy S Bejarano, MPH

857-215-2365oldy_bejarano@dfci.harvard.edu

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Andrew Hantel, MD

617-582-9394Andrew_Hantel@dfci.harvard.edu

Principal Investigator:

Andrew Hantel, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Blood Cancer
  • Leukemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-07-16.