Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DIVERSE Review Process.
- Who it may be relevant to
- Registry conditions: Blood Cancer, Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Other 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 measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Dana-Farber Cancer Institute — Boston
Identifiers
NCT: NCT06469307 · 24-177 · K08CA273043