Blood CancerDIVERSENCT06469307
Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)
A study testing DIVERSE Review Process in people with Blood Cancer and Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Cancer, Leukemia
- What is being tested?
- DIVERSE Review Process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2024to 30 Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Andrew Hantel, MD, 617-582-9394, Andrew_Hantel@dfci.harvard.edu
Andrew Hantel, MD
About this study
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.
Read the 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.
- Conditions
- Blood Cancer, Leukemia
- Being tested
- DIVERSE Review Process
- Keywords
- Blood Cancer, Leukemia
- Medical subject headings
- Hematologic Neoplasms, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIVERSE Review ProcessOther
Also called DIVERSE
A participant and community-based review system for clinical research protocols that elicits and collects feedback on investigator-initiated protocol reviews.
| Study group | Role | What they receive |
|---|---|---|
| DIVERSE Community Advisory Board (CAB) | Other | Enrolled participants will complete:
* Confidentiality agreement and demographic questionnaire
* Online training and in-person or remote training with study team
* Timely DIVERSE review of protocols
* Audio recorded meeting (in-person, remote, or via phone call) with study team to present review findings
* Semi-structured exit interview and/or focus group with study staff to provide feedback Receives: Other: DIVERSE Review Process |
| DIVERSE Investigators | Other | Enrolled investigator participants will complete:
* Brief Feedback Survey
* Request DIVERSE reviews and complete request form
* Acceptability of Intervention Measure questionnaire
* Semi-structured exit interview and/or focus group with study staff to provide feedback Receives: Other: DIVERSE Review Process |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start9 Dec 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Society of Clinical Oncology
- Responsible party
- Principal investigator, Andrew Hantel, MD, Dana-Farber Cancer Institute
- Investigators
- Andrew Hantel, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469307
- Sponsor's protocol ID
- 24-177
- Other IDs
- K08CA273043
- Acronym
- DIVERSE
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.