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

M.D. Anderson Cancer Center

Status: Begins enrollment in 7 months

Conditions: Prostate Carcinoma

Treatments: Behavioral: Behavioral Intervention; Other: Survey Administration; Other: Interview; Other: Electronic Health Record Review; Procedure: Biospecimen Collection; Other: Genetic Testing; Other: Genetic Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT07377006

NCI-2025-06571 (Registry Identifier)

2025-1272 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed prostate cancer patients receiving care at Lyndon B. Johnson (LBJ) Hospital
• Were recommended for germline genetic testing by their oncology provider
• Can provide informed consent
• Can communicate in English or Spanish

Exclusion criteria

• Prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

Group 1 (Qualitative interview)

Other group

Description:

Patients complete a qualitative interview that informs the development of the decision support tool.

Treatment:

Other: Interview

Other: Electronic Health Record Review

Other: Interview

Group 2 (Draft decision support tool, cognitive interview)

Other group

Description:

Patients view the draft of the decision support tool and complete cognitive interviews for the refinement of the decision support tool on study.

Treatment:

Other: Interview

Other: Interview

Behavioral: Behavioral Intervention

Group 3 (Decision tool)

Experimental group

Description:

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.

Treatment:

Other: Genetic Counseling

Other: Genetic Testing

Procedure: Biospecimen Collection

Other: Survey Administration

Behavioral: Behavioral Intervention