Clinical trial NCT06469307: Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)
Official title: Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Cancer
Leukemia
Keywords: Blood Cancer
Leukemia
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: American Society of Clinical Oncology
First posted: 2024-06-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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

Primary outcomes:
measure: Protocol Review Completion Rate
timeFrame: 18 months
measure: Protocol Review Completion Rate Within 35 Days
timeFrame: 18 months
measure: Proportion of Acceptability of Intervention Measure (AIM) Scores of 10 or Greater
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Andrew Hantel, MD
role: PRINCIPAL_INVESTIGATOR
References: