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

NCT ID: NCT06171139

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2027-08-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Stage 1: Tool Development

Participants will participate in a semi-structured qualitative interview either by phone, video conference or in-person. A trained interviewer will interview eligible, consenting participants using a semi-structured interview guide to meet objectives. The interview guide is based on The Patient Education Materials Assessment Tool (PEMAT) and the COM-B (capability (C), opportunity (O), and motivation (M))/Behaviour Change Wheel (BCW) framework and will be used to determine an implementation strategy. The interview will be audio-recorded, transcribed verbatim, and analyzed.

Group Type: EXPERIMENTAL

Counseling Tool

Intervention Type: OTHER

Non-therapeutic educational intervention

Questionnaires

Intervention Type: OTHER

Participants will complete questionnaires online, via mail, by telephone, or in person per participant preference.

Stage 1: Tool Implementation (Pilot Study)

Participants will receive the tumor genetic pre-test counseling tool informed by results and themes identified in Stage 1. Participants will receive the non-therapeutic intervention, a pre-TGT counseling tool, and complete pre- and post-intervention surveys and a attend a brief post-intervention interview.

Group Type: EXPERIMENTAL

Counseling Tool

Intervention Type: OTHER

Non-therapeutic educational intervention

Questionnaires

Intervention Type: OTHER

Participants will complete questionnaires online, via mail, by telephone, or in person per participant preference.

Interventions

Counseling Tool

Non-therapeutic educational intervention

Intervention Type: OTHER

Questionnaires

Participants will complete questionnaires online, via mail, by telephone, or in person per participant preference.

Intervention Type: OTHER

Other Intervention Names

Surveys

Eligibility Criteria

Inclusion Criteria

Stage 1:

1. Age 18-years-old or older

2. Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race including Black or African American is included.

3. Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.

4. Able to understand study procedures and to comply with them for the entire length of the study.

5. Able to understand a written information sheet and willing to verbally consent.

6. Fluent in English (reading, writing, and speaking)

Stage 2:

1. Age 18-years-old or older

2. Identifies as Black or African-American, by either chart documentation or participant self-report. Mixed-race including Black or African-American is included.

3. Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.

4. Able to understand study procedures and to comply with them for the entire length of the study.

5. Fluent in English (reading, writing, and speaking).

6. Anticipated discussion of TGT within 0-90 days of enrollment, per treating oncology provider's discretion. TGT involves use of any cancer genetic sequencing (whether standard-of-care or part of a research protocol) via any one of the following:

1. Somatic DNA testing of already-collected tissue.

2. Somatic DNA testing of tissue to be collected in the future via biopsy, surgery, or other procedure.

3. Blood-based DNA testing to evaluate for circulating tumor DNA.

7. Able to understand a written informed consent document and willing to sign it.

Exclusion Criteria

Contraindication to any study-related procedure or assessment in either stage.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Prostate Cancer Foundation

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Kwon, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel Avins

Role: CONTACT

Daniel.Avins@ucsf.edu

877-827-3222

Facility Contacts

Daniel Avins

Role: primary

Daniel.Avins@ucsf.edu

Role: backup

cancertrials@ucsf.edu

877-827-3222

Other Identifiers

NCI-2023-10339

Identifier Type: OTHER

Identifier Source: secondary_id

23553

Identifier Type: -

Identifier Source: org_study_id