NCT07377006

Decision Support Tool to Enhance Germline Genetic Testing for Patients With Prostate Cancer

Efforts to Enhance Germline Genetic Testing at Lyndon B. Johnson Hospital

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. Identify patient, provider, and health system factors contributing to the completion of recommended germline testing for men with prostate cancer. II. Develop a decision support tool for patients tailored to the cultural and socioeconomic context of the local community. III. Conduct a pilot intervention trial to evaluate a point-of-care decision support tool in a public safety net hospital in Harris County, Texas. SECONDARY OBJECTIVES: I. Assess the feasibility of point-of-care decision support tool in a public safety net hospital in Harris County, Texas. II. Assess the change in completion of germline genetic testing with utilization of the decision support tool. OUTLINE: At each stage of the proposed research, patients are recruited to 1 of 3 groups. Groups 1 and 2 are observational and group 3 is a pilot interventional trial. GROUP 1: Patients complete a qualitative interview that informs the development of the decision support tool. GROUP 2: Patients view the draft of the decision support tool and complete cognitive interviews for the refinement of the decision support tool on study. GROUP 3: 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.

Conditions

• Prostate Carcinoma

Interventions

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

Timeline

• Start date: 2026-10-01
• Primary completion: 2030-05-31
• Completion: 2030-12-31
• First posted: 2026-01-29
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States