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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Stage 2: A pilot study of participants who are planning to have a discussion about undergoing tumor genetic testing with their oncology provider will be invited to join and utilize the tool, and answer questionnaires about the tool."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at a tool to help Black or African American men learn about tumor genetic testing before it happens. This testing looks for gene changes in cancer. The study is for men with prostate cancer that has spread and aims to make this support more fair and easier to use in care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Identify as Black or African American, including mixed-race people who are Black or African American.
  • Have prostate cancer that has spread to other parts of the body. Medical records or your own report can confirm this; a lab report is not needed.
  • Be able to understand and follow study steps for the whole study.
  • Be fluent in reading, writing, and speaking English.
  • Stage 1: Be able to understand a written study information sheet and agree out loud to join.
  • Stage 2: Your cancer doctor expects a discussion about tumor genetic testing within 365 days of joining. Testing may use tumor tissue already collected, tissue collected later, or blood.
  • Stage 2: Be able to understand and sign a written form agreeing to join.

Who can't join

  • In either stage, have a medical reason that makes any study procedure or assessment unsafe or unsuitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Stage 1: 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) Stage 2: 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 0-365 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: 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. Exclusion Criteria: Contraindication to any study-related procedure or assessment in either stage.

Study sites (1)

CA