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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
40
A participant and community-based review system for clinical research protocols that elicits and collects feedback on investigator-initiated protocol reviews.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGProtocol 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 months
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 months
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 months
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