Educational Intervention for Prostate Cancer

Overseen By Christine Wang

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Prior genetic test, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Educational Intervention for Prostate Cancer?

Genetic testing is recommended for prostate cancer patients as it helps in selecting targeted therapies and clinical trial options, which can lead to better outcomes. This approach is supported by guidelines from the National Comprehensive Cancer Network and is endorsed by multiple professional societies, highlighting its importance in personalized care. ^{1 2 3 4 5}

Is genetic testing for prostate cancer safe for humans?

The research does not specifically address safety concerns related to genetic testing for prostate cancer, but it is generally considered safe as it involves analyzing DNA from a blood or saliva sample to identify genetic mutations. ^{1 2 5 6 7}

How is the treatment involving community-based health coaching and genetic testing for prostate cancer different from other treatments?

This treatment is unique because it combines community-based health coaching with genetic testing to personalize prostate cancer care. Genetic testing helps identify inherited risks and tailor precision therapies, while health coaching supports patients in understanding and managing their condition effectively. ^{1 5 8 9 10}

Research Team

Daniel Kwon, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for African American men over 18 with regional, advanced, or metastatic prostate cancer who speak English and haven't been found to have a genetic mutation linked to high cancer risk. It's not open to those outside this group.

Inclusion Criteria

I have been diagnosed with advanced or metastatic prostate cancer.

I am 18 years old or older.

I do not have any known genetic mutations linked to cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Educational Session and Survey

Participants engage in an educational session with a health coach and complete surveys about genetic testing knowledge, attitudes, and awareness

1 day

1 visit (in-person or virtual)

Genetic Testing

Participants may undergo germline genetic testing

1 day

Follow-up

Participants complete exit surveys and are monitored for decisional conflict and genetic testing outcomes

up to 2 days

1 visit (in-person or virtual)

Treatment Details

Interventions

• Community-Based Health Coach
• Educational Intervention
• Genetic Testing
• Survey Administration

Trial Overview The study tests if education on genetic testing by a health coach can improve understanding and attitudes towards germline genetic testing among African American men with prostate cancer.

Participant Groups

Group I: Cohort B (educational session, survey, genetic testing) Experimental Treatment 3 Interventions

Patients participate in educational session with health coach over 60 minutes. Patients 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. Patients may undergo genetic testing.

Group II: Cohort A (survey, genetic testing) Active Control 2 Interventions

Patients 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. Patients may also undergo genetic testing.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Lazarex Cancer Foundation

Collaborator

Trials

2

Recruited

260+

Findings from Research

Inherited genetic mutations significantly increase the risk of prostate cancer and are linked to more aggressive disease, making germline genetic testing crucial for patients with advanced or metastatic prostate cancer to guide treatment options.

The National Comprehensive Cancer Network now recommends genetic testing for all men with prostate cancer and those at high risk based on family history, highlighting the need for primary care providers to be educated on genetic testing's role in screening and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic testing in prostate cancer management: Considerations informing primary care. Giri, VN., Morgan, TM., Morris, DS., et al.[2022]

Integrating a hereditary cancer risk assessment (HCRA) process in community urology clinics significantly increased the rate of genetic testing among prostate cancer patients, from 4.2% to 8.7%, indicating improved awareness and accessibility of genetic testing.

The majority of healthcare providers and patients found the HCRA process valuable, with 61% of providers considering it as important as other assessments and 84.7% of patients believing the genetic test results were crucial for their future cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hereditary cancer risk assessment and genetic testing in the community urology practice setting. Shore, ND., Lenz, L., Cogan, ES., et al.[2022]

Out of 52 large community urology practices surveyed, 63% are already offering hereditary testing for prostate cancer to select patients, indicating a growing acceptance of genetic testing in this field.

The main barriers to implementing hereditary testing include concerns about medical/legal liability (22%), reimbursement issues (20%), and the challenges of entering comprehensive family histories into electronic health records (18%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Germline testing for prostate cancer: community urology perspective. Concepcion, RS.[2020]

Genetic testing plays a crucial role in guiding screening and treatment decisions for men with prostate cancer, which is one of the most common cancers among men in the U.S.

Understanding and integrating genomic test results can help healthcare providers and patients create personalized treatment plans, improving the overall care for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genomics to personalize care of prostate cancer. Connors, LM.[2021]

Genetic testing for prostate cancer is becoming more common, especially in men with metastatic disease, where up to 15% may have germline pathogenic variants that can inform precision therapy options.

Effective pre-test discussions about genetic testing are crucial, as they cover hereditary cancer risks, testing purposes, and potential results, which can significantly impact patient management and family health strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Germline testing and genetic counselling in prostate cancer. Russo, J., Giri, VN.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Genetic testing in prostate cancer management: Considerations informing primary care. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Hereditary cancer risk assessment and genetic testing in the community urology practice setting. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Germline testing for prostate cancer: community urology perspective. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Genomics to personalize care of prostate cancer. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Germline testing and genetic counselling in prostate cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Risk management actions following genetic testing in the Cancer Health Assessments Reaching Many (CHARM) Study: A prospective cohort study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Pilot Trial of Streamlined Genetic Education and Traceback Genetic Testing in Prostate Cancer Survivors. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

What do men understand about lifetime risk following genetic testing? The effect of context and numeracy. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

The beliefs, and reported and intended behaviors of unaffected men in response to their family history of prostate cancer. [2019]

10. England pubmed.ncbi.nlm.nih.gov

A cluster-randomised, parallel group, controlled intervention study of genetic prostate cancer risk assessment and use of PSA tests in general practice--the ProCaRis study: study protocol. [2021]