Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
DIVERSE Review Process
Other interventionA participant and community-based review system for clinical research protocols that elicits and collects feedback on investigator-initiated protocol reviews.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: DIVERSE Community Advisory Board (CAB)Other 1 intervention
Group B: DIVERSE InvestigatorsOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
18 months2
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.
Time frame
18 months3
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.
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator
American Society of Clinical Oncology
Collaborator
Source ClinicalTrials.gov