RightFit
RecruitingNot applicable

Community-Based Health Coach for Access to Germline Genetic Testing Among African American Men With Prostate Cancer

Navigate Study: Use of a Community-Based Health Coach to Improve Access to Germline Genetic Testing Among African American Men With 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
  • "CLOSED TO ENROLLMENT: INITIAL PILOT COHORT A: Participants complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up."
  • "Participants also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up."
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 what makes it hard for Black or African American men with prostate cancer to get tests for inherited gene changes. It tests whether education from a community health coach helps men learn about these tests and changes their views. It is for men with advanced prostate cancer, including cancer that has spread to lymph nodes or other body parts.

This clinical trial studies barriers to genetic testing in African American men with prostate cancer and whether tailored, culturally relevant genetic testing education provided by a community-based health coach is beneficial in improving knowledge, attitudes, and awareness of genetic testing. Information gained from this study, may help researchers better understand and learn more about how to increase access to germline genetic testing in underrepresented populations.

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

Eligibility

Who can join

  • Parts 1 and 2 are enrolling. The first pilot group is closed.
  • Patients in Parts 1 and 2 must be at least 18 and identify as Black or African American.
  • Patients must report having advanced prostate cancer or prostate cancer that has spread to lymph nodes or other body parts.
  • Everyone must speak and read English, understand the study steps, and be able to follow them for the whole study.
  • In Part 1, patients may join whether or not they have had testing for inherited gene changes. They must be able to give spoken consent to join.
  • Part 1 also accepts doctors who treat cancer with medicines and genetics providers. They must be able to give spoken consent.
  • In Part 2, patients must have no known gene change linked to cancer risk and must be able to give written consent.
  • Part 2 patients recruited from a clinic must have a cancer care visit within 3 months where testing for inherited gene changes will be discussed.

Who can't join

  • Parts 1 and 2: You cannot join if a study step or test would be unsafe or medically unsuitable for you.
  • Part 2: You cannot join if you report having had a test for inherited gene changes before.
  • Closed pilot group: People were excluded if they had prior testing for inherited gene changes, were under 18, or could not read or answer forms.

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

Official eligibility criteria

Inclusion Criteria: CLOSED TO ENROLLMENT: INITIAL PILOT COHORT: Participants: 1. Age \>=18 years old. 2. Able to speak and read in English. 3. Have no known cancer risk genetic mutation. 4. Self-identify as Black or African American. 5. Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines. ENROLLING: PART 1: Participants: 1. Age \>=18 years old. 2. Able to speak and read in English. 3. Able to understand study procedures and to comply with them for the entire length of the study. 4. Able to verbally consent. 5. Self-identifies as Black or African-American. 6. Self-reports a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer. Note: Participants may or may not have had germline testing in the past, as a range of experiences is valuable for holistic feedback. Providers: 1. Self-identifies as a medical oncologist or genetics provider. 2. Able to speak and read in English. 3. Able to understand study procedures and to comply with them for the entire length of the study. 4. Able to verbally consent. ENROLLING: PART 2: Participants: 1. Age \>=18 years old. 2. Able to speak and read in English. 3. Able to understand study procedures and to comply with them for the entire length of the study. 4. Able to provide written informed consent. 5. Have no known cancer risk genetic mutation. 6. Self-identify as Black or African American. 7. Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per NCCN guidelines. 8. For patients recruited from the clinic: Presence of an oncology appointment within 3 months where germline testing will be discussed. Exclusion Criteria: CLOSED TO ENROLLMENT: INITIAL PILOT COHORT. 1. Prior germline genetic test. 2. Age \<18 years old. 3. Unable to read or answer forms. ENROLLING: PART 1: 1\. Contraindication to any study-related procedure or assessment. ENROLLING: PART 2: 1. Self-reports prior germline genetic test. 2. Contraindication to any study-related procedure or assessment.

Study sites (3)

CA