Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)

Leukemia Clinical Trial

— DIVERSE  

Official title:

Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06469307
• Other study ID #: 24-177
• Secondary ID: K08CA273043
• Status: Not yet recruiting
• Start date: November 2024
• Est. completion date: January 1, 2028

Study information

• Verified date: June 2024
• Source: Dana-Farber Cancer Institute
• Contact: Andrew Hantel, MD
• Phone: 617-582-9394
• Email: Andrew_Hantel[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Cancer
• Hematologic Neoplasms
• Leukemia

Intervention

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.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	American Society of Clinical Oncology, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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