Recruiting

Genomic Counseling

Sponsor:

UCLA

Code:

NCT06171139

Conditions

Prostate Cancer

Prostate Cancer Metastatic

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Counseling Tool

Questionnaires

Study Details

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.

Conditions

Prostate Cancer

Prostate Cancer Metastatic

Study ID

NCT06171139

Start date

Dec 1, 2023

Status verified date

Apr, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 0-365 days of enrollment, per treating oncology provider's discretion. TGT involves the 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

Counseling Tool

Non-therapeutic educational intervention

Questionnaires

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

Primary outcome measure

  • Frequency of participant responses (Stage 1) [ Time Frame: 1 day ]
  • Proportion of enrolled participants (Stage 2) [ Time Frame: 1 day ]
  • Proportion of enrolled participants who review all educational materials (Stage 2) [ Time Frame: Up to 60 days ]
  • Mean score of Feasibility of Intervention Measure (FIM) (Stage 2) [ Time Frame: Up to 60 days ]

Central Contacts and Locations

Central contacts

Locations

University of California

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Daniel Kwon, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-04-16.