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 — BEHAVIORAL
    View decision support tool
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Genetic Counseling — OTHER
    Meet with genetic counselor
  • Genetic Testing — OTHER
    Undergo standard of care genetic testing
  • Interview — OTHER
    Complete qualitative interview
  • Interview — OTHER
    Complete cognitive interview
  • Survey Administration — OTHER
    Ancillary 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)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Debanjan Pain
713-563-0020
Debanjan Pain (PRINCIPAL_INVESTIGATOR)

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