RECRUITING

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

Conditions

Prostate Cancer Prostate Cancer Metastatic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-01

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06171139

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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) 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 0-90 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: 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

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)
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 0-90 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:
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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Daniel Avins

CONTACT

877-827-3222

Daniel.Avins@ucsf.edu

Principal Investigator

Daniel Kwon, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Daniel Kwon, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-12-01

Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer
Prostate Cancer Metastatic