Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)
NCT ID: NCT06469307
Last Updated: 2025-06-03
Study Results
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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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-12-09
2027-06-30
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
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
DIVERSE Review Process
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
DIVERSE Review Process
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
American Society of Clinical Oncology
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Andrew Hantel, MD
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-177
Identifier Type: -
Identifier Source: org_study_id
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