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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

∙ Stage 1:

• Age 18-years-old or older

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

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

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

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

• Fluent in English (reading, writing, and speaking)

∙ Stage 2:

• Age 18-years-old or older

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

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

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

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

• 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:

‣ Somatic DNA testing of already-collected tissue.

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

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

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

Locations
United States
California
University of California
RECRUITING
San Francisco
Contact Information
Primary
Daniel Avins
Daniel.Avins@ucsf.edu
877-827-3222
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 80
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: Prostate Cancer Foundation

This content was sourced from clinicaltrials.gov