Blood Cancer, Leukemia
Conditions
Keywords
Blood Cancer, Leukemia
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.
Interventions
OTHERDIVERSE Review Process
A participant and community-based review system for clinical research protocols that elicits and collects feedback on investigator-initiated protocol reviews.
Sponsors
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
American Society of Clinical Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protocol Review Completion Rate | 18 months | 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. |
| Protocol Review Completion Rate Within 35 Days | 18 months | 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. |
| Proportion of Acceptability of Intervention Measure (AIM) Scores of 10 or Greater | 18 months | 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. |
Countries
United States
Contacts
CONTACTAndrew Hantel, MD
CONTACTOldy S Bejarano, MPH
PRINCIPAL_INVESTIGATORAndrew Hantel, MD
Dana-Farber Cancer Institute
Outcome results
None listed