Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)
DIVERSE
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2024
CompletedFirst Posted
Study publicly available on registry
June 21, 2024
CompletedStudy Start
First participant enrolled
December 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
June 3, 2025
May 1, 2025
1.6 years
June 17, 2024
May 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Protocol Review Completion Rate
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.
18 months
Protocol Review Completion Rate Within 35 Days
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.
18 months
Proportion of Acceptability of Intervention Measure (AIM) Scores of 10 or Greater
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.
18 months
Study Arms (2)
DIVERSE Community Advisory Board (CAB)
OTHEREnrolled 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
DIVERSE Investigators
OTHEREnrolled 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
A participant and community-based review system for clinical research protocols that elicits and collects feedback on investigator-initiated protocol reviews.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Age 18 older
- English Speaking
- Site or Principal investigator
- Not a member of the research team
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
- American Society of Clinical Oncologycollaborator
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Hantel, MD
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 17, 2024
First Posted
June 21, 2024
Study Start
December 9, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
June 3, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.