- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06795139
Pilot of a Trial Enrollment Diversity Dashboard (TEDD)
Feasibility Pilot of a Trial Enrollment Diversity Dashboard (TEDD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is about testing a tool called the Trial Enrollment Diversity Dashboard (TEDD) to see if it can help increase diversity in cancer clinical trials, specifically for leukemia. Clinical trials are important for developing new cancer treatments, but not all groups are equally represented in these trials. This can lead to treatments that may not work as well for everyone.
The TEDD tool is designed to give medical professionals feedback on how diverse their patient enrollments are clinical trials. By using this tool, medical professionals can see if they are enrolling a diverse group of patients and make changes if needed.
The study will involve a small group of medical professionals who treat leukemia patients. They will use the TEDD tool and provide feedback on its usability and effectiveness. Study procedures include completion of surveys and usage of the TEDD intervention dashboard.
It is expected that about 12 medical professionals will take part in this research study. Participation in this research study is expected to last about 14 months.
The National Cancer Institute is providing funding for this research study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria Medical Professionals:
Physician, nurse practitioner, or physician assistant
-≥10% clinical effort (or one ½ day of clinic per week for those working <1 FTE)
- Treats adult patients with leukemia or related diseases at the study sites
- Ability to understand and willingness to provide informed consent
- Age 18 or older
Inclusion Criteria Participant Population:
- Age ≥18 years old
- Diagnosis of leukemia, lymphoma, myeloma, or related diseases
- Seen by a physician for this diagnosis at one of the study sites
Exclusion Criteria Medical Professionals:
-Listed member of the research team
Exclusion Criteria Participant Population:
-Participants without the diagnoses of interest listed above, participants not seen at the study sites.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TEDD Intervention
12 medical professional participants will complete the following:
|
A data management and classification algorithm tool that provides personalized enrollment diversity performance data for clinician review and which aims to overcome race-ethnic disparities in Leukemia clinical trial participation.
Data inputs and the Dashboard are within existing HIPAA-complaint electronic health records systems used at Dana-Farber Cancer Institute, and utilization data metrics are collected through the Tableau software supporting the intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TEDD Utilization Rate
Time Frame: 12 months
|
Utilization will be measured as the proportion of quarters where a participant accessed the dashboard divided by the total number of study quarters.
Based on 12 participants over 4 three-month quarters, there are a total of 48 person-quarters available for analysis.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew Hantel, MD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-544
- K08CA273043-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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