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| ID | Type | Description | Link |
|---|---|---|---|
| K08CA273043 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| American Society of Clinical Oncology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DIVERSE Community Advisory Board (CAB) | Other | Enrolled participants will complete:
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| DIVERSE Investigators | Other | Enrolled investigator participants will complete:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIVERSE Review Process | Other | A participant and community-based review system for clinical research protocols that elicits and collects feedback on investigator-initiated protocol reviews. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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CAB Participant Inclusion Criteria:
CAB Participant Exclusion Criteria:
Investigator Participant Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Hantel, MD | Contact | 617-582-9394 | Andrew_Hantel@dfci.harvard.edu | |
| Oldy S Bejarano, MPH | Contact | 857-215-2365 | oldy_bejarano@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Hantel, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| D009370 |
| Neoplasms by Histologic Type |