Enhancing diversity in clinical trial enrollment through community engagement
Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)
NA · Dana-Farber Cancer Institute · NCT06469307
This study is trying to see if getting feedback from patients and community members can help make clinical trials for blood cancer and leukemia more inclusive and diverse.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06469307 on ClinicalTrials.gov |
What this trial studies
This research focuses on improving inclusion and diversity in clinical trial enrollment for blood cancer and leukemia by implementing a community-based protocol review process called DIVERSE. Participants, including patients and community members, will undergo specialized training to provide feedback on clinical trials in development. The study aims to assess the feasibility, acceptability, and preliminary efficacy of this process over an 18-month period. The initiative is supported by the National Cancer Institute and the American Society of Clinical Oncology.
Who should consider this trial
Good fit: Ideal candidates include English-speaking adults aged 18 or older who are in remission from blood cancer for more than one year.
Not a fit: Patients who are unable to provide consent, are under 18 years old, or do not speak English may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more diverse representation in clinical trials, ultimately improving treatment outcomes for underrepresented populations.
How similar studies have performed: While the approach of community-based participatory research is gaining traction, this specific protocol review process is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Andrew Hantel, MD — Dana-Farber Cancer Institute
- Study coordinator: Andrew Hantel, MD
- Email: Andrew_Hantel@dfci.harvard.edu
- Phone: 617-582-9394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Blood Cancer, Leukemia