Decision Support Tool to Enhance Germline Genetic Testing for Patients With Prostate Cancer
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT07377006
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Behavioral Intervention — BEHAVIORALView decision support tool
- Biospecimen Collection — PROCEDUREUndergo blood sample collection
- Electronic Health Record Review — OTHERAncillary studies
- Genetic Counseling — OTHERMeet with genetic counselor
- Genetic Testing — OTHERUndergo standard of care genetic testing
- Interview — OTHERComplete qualitative interview
- Interview — OTHERComplete cognitive interview
- Survey Administration — OTHERAncillary studies
Study Details
This clinical trial identifies factors associated with completing genetic testing, aids in the development of a decision support tool, and tests how well the decision support tool works to enhance germline genetic testing in patients with prostate cancer. Germline genetic testing is a guideline-recommended standard of care for many patients with prostate cancer. Completing genetic testing can enable the use of targeted therapies, offers access to novel clinical trials, provides valuable information, and can help identify at risk family members. The decision support tool may educate patients and assist in the decision to engage with germline genetic testing.
Key Dates
- Start date
- Oct 1, 2026
- Status verified
- Feb 2026
- Primary completion
- May 31, 2030
- Completion
- Dec 31, 2030
Study Design
- Enrollment
- 108 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Other: Group 1 (Qualitative interview)Patients complete a qualitative interview that informs the development of the decision support tool.
- Other: Group 2 (Draft decision support tool, cognitive interview)Patients view the draft of the decision support tool and complete cognitive interviews for the refinement of the decision support tool on study.
- Experimental: Group 3 (Decision tool)Patients view the decision support tool that provides culturally tailored information about genetic testing and the collection process. Patients may then provide a blood sample for standard of care genetic testing and may additionally meet with a genetics counselor for additional information prior to testing. Patients with a positive germline genetic mutation will discuss results with a genetics counselor.
Primary Outcome Measure
Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | Debanjan Pain (PRINCIPAL_INVESTIGATOR) |
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