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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Counseling Tool — OTHER
    Non-therapeutic educational intervention
  • Questionnaires — OTHER
    Participants 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 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.

Primary Outcome Measure

Frequency of participant responses (Stage 1) [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of CaliforniaSan FranciscoCalifornia94143
Daniel Avins
877-827-3222
Daniel Kwon, MD (PRINCIPAL_INVESTIGATOR)

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