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

NCT06171139 | Recruiting

• 2 other identifiers: 23553NCI-2023-10339
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Frequency of participant responses (Stage 1)

  Participant-reported perspectives of intervention in a semi-structured interview will be collected during Stage 1 and reviewed and will be explored using thematic analysis. A codebook will be created using the PEMAT (for the primary objective) described in the interview guide. This framework provides a systematic approach for identifying behavior change models evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behavior. This will produce evidence-based behavior change techniques most likely to be effective. Emergent codes and themes will be added throughout thematic analysis. Two coders will code each interview (one primary and one secondary coder). Discrepancies will be negotiated to consensus.

  1 day

• Proportion of enrolled participants (Stage 2)

  The proportion of participants who enrolled in the study after being approached by their healthcare team will be reported.

  1 day

• Proportion of enrolled participants who review all educational materials (Stage 2)

  The proportion of all enrolled participants who utilized and reviewed all of the educational materials in the tool will be reported.

  Up to 60 days

• Mean score of Feasibility of Intervention Measure (FIM) (Stage 2)

  Scores on the FIM will be averaged across all participants. Items will be scored on a 5-point scale: 1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5= Completely agree. A higher mean score indicates greater feasibility. The mean score and standard deviation will be reported.

  Up to 60 days

Secondary Outcomes (8)

• Mean score of Acceptability of Intervention Measure (AIM) (Stage 2)

  Up to 60 days

• Mean score of investigator-developed, measure of acceptability items (Stage 2)

  Up to 60 days

• Mean score of cancer genomic testing knowledge (Stage 2)

  Up to 60 days

• Proportion of participants who select correct response in each genomic testing knowledge instrument item (Stage 2)

  Up to 60 days

• Proportion of participants who answer "Yes" to each attitude item in the Attitude and expectations for tumor genetic testing survey (Stage 2)

  Up to 60 days

Study Arms (2)

Stage 1: Tool Development

EXPERIMENTAL

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.

Other: Counseling Tool; Other: Questionnaires

Stage 1: Tool Implementation (Pilot Study)

EXPERIMENTAL

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.

Other: Counseling Tool; Other: Questionnaires

Interventions

Questionnaires OTHER

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

Also known as: Surveys

Stage 1: Tool Development; Stage 1: Tool Implementation (Pilot Study)

Counseling Tool OTHER

Non-therapeutic educational intervention

Stage 1: Tool Development; Stage 1: Tool Implementation (Pilot Study)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 0-365 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:
• Somatic DNA testing of already-collected tissue.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Prostate Cancer Foundation: collaborator

Study Sites (1)

University of California

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Daniel Kwon, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Avins

CONTACT

877-827-3222; Daniel.Avins@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)