NCT06171139

Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Prostate Cancer

Developing and Testing a Patient-centered Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Metastatic Prostate Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall goal of the study is to improve equitable delivery of pre-Tumor genetic testing (TGT) counseling tool for Black or African American men with metastatic prostate cancer and evaluating the tool for implementation.

Detailed description

PRIMARY OBJECTIVES: Stage 1: To evaluate education quality of the intervention in Black or African American men with prostate cancer. Stage 2: To evaluate feasibility of the TGT intervention among Black or African American men with prostate cancer SECONDARY OBJECTIVES: Stage 1: 1. To evaluate completeness of the intervention content. 2. To identify barriers and facilitators for using the intervention. Stage 2: 1. To evaluate the acceptability of the intervention among Black or African American men with prostate cancer. 2. To evaluate change in participant knowledge about tumor genetic testing among Black or African American men with prostate cancer. 3. To evaluate change in patient attitudes toward tumor genetic testing among Black or African American men with prostate cancer. 4. To evaluate change in participant expectations of tumor genetic testing among Black or African American men with prostate cancer. 5. To evaluate patient perspectives on the intervention. 6. To evaluate the rate of TGT among Black or African American men with prostate cancer who have received the tumor genetic pre-test counseling tool. OUTLINE: This is a two-stage study. In Stage 1, Adult Black or African American men with metastatic prostate cancer who have not made a decision about TGT, or who have decided to undergo TGT, or patients who have decline TGT about tumor genetic testing will participate in development by answering questionnaires and utilizing the pilot application for up to 60 days. The investigators will then refine the tool to be piloted in Stage 2. Stage 2: A pilot study of participants who are planning to have a discussion about undergoing tumor genetic testing with their oncology provider will be invited to join and utilize the tool, and answer questionnaires about the tool.

Conditions

• Prostate Cancer
• Prostate Cancer Metastatic

Interventions

Type	Name	Description
OTHER	Counseling Tool	Non-therapeutic educational intervention
OTHER	Questionnaires	Participants will complete questionnaires online, via mail, by telephone, or in person per participant preference.

Timeline

• Start date: 2023-12-01
• Primary completion: 2027-05-31
• Completion: 2027-08-31
• First posted: 2023-12-14
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States