Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Prostate Cancer
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT06171139
- Status
- Recruiting
Conditions
- Prostate Cancer
- Prostate Cancer Metastatic
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Counseling Tool — OTHERNon-therapeutic educational intervention
- Questionnaires — OTHERParticipants will complete questionnaires online, via mail, by telephone, or in person per participant preference.
Study Details
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.
Key Dates
- Start date
- Dec 1, 2023
- Status verified
- Apr 2026
- Primary completion
- May 31, 2027
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Stage 1: Tool DevelopmentParticipants 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.
Primary Outcome Measure
Frequency of participant responses (Stage 1) [ Time Frame: 1 day ]
Central Contacts
- Daniel Avins877-827-3222
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California | San Francisco | California | 94143 | Daniel Avins 877-827-3222 Daniel Kwon, MD (PRINCIPAL_INVESTIGATOR) |
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