Educational Intervention for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Lauren Trihy

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

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand and overcome barriers to genetic testing in African American men with prostate cancer. It explores whether a community-based health coach can enhance awareness and attitudes towards genetic testing through culturally relevant education. Participants may engage in educational sessions and complete surveys to share their knowledge and beliefs about genetic testing. The trial seeks African American men with prostate cancer that has spread to lymph nodes or more advanced stages. As an unphased study, this trial offers a unique opportunity to contribute to research that could improve genetic testing access and education in the community.

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 prior data suggests that this educational intervention is safe?

Research shows that community-based health coaching is generally manageable for participants. These programs help patients make better decisions and improve their quality of life. No major negative side effects have been reported from this type of program.

Genetic testing is a common part of prostate cancer care. Studies indicate its importance in understanding cancer risk. Most patients handle genetic testing well, with no major negative effects reported. However, collecting genetic information may be sensitive for some individuals. Overall, both coaching and genetic testing have been used safely in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative methods to enhance prostate cancer care through community-based health coaching and genetic testing. Unlike traditional treatments that primarily focus on medical interventions like surgery, radiation, or hormone therapy, this trial emphasizes education and personalized risk assessment. The use of health coaches and ProGene chatbots offers a more personalized and accessible approach, potentially increasing patient engagement and understanding. By integrating genetic testing, the trial aims to provide insights into individual risk factors, enabling more tailored and effective management strategies for prostate cancer.

What evidence suggests that this trial's educational intervention and genetic testing could be effective for prostate cancer?

Research has shown that community health coaching, one of the interventions in this trial, helps prostate cancer patients better understand their condition and make informed decisions. Studies have found that patients working with community health workers or guides often experience better health outcomes and increased access to care.

Genetic testing, another intervention in this trial, effectively identifies gene changes linked to prostate cancer, aiding in treatment decisions. One study found that over 74% of patients gained important information from genetic testing. These efforts aim to improve knowledge and access to care for groups that may lack support, such as African American men with prostate cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Daniel Kwon, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Self-identify as Black or African American

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Part 2 Pilot (educational session, survey, genetic testing) Experimental Treatment 5 Interventions

Clinical participants engage in educational session lasting about 15-30 minutes with health coach in-person or remotely who will be using a ProGene chatbot to augment the session. Participants also complete surveys about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences. Community and clinical participants may undergo genetic testing.

Group II: Part 1 (educational session, survey, genetic testing) Experimental Treatment 5 Interventions

Participants engage in educational session lasting 15-30 minutes with health coach in-person or remotely who will be using a ProGene chatbot to augment the session over 15-30 minutes. Participants also complete surveys about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences. Participants may undergo genetic testing.

Group III: CLOSED TO ENROLLMENT -Initial Pilot Cohort B (educational session, survey, genetic testing) Experimental Treatment 3 Interventions

Participants engage in educational session with health coach over 60 minutes. 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. Participants may undergo genetic testing. Participant and provider interviews will be conducted at end of study.

Group IV: CLOSED TO ENROLLMENT - Initial Pilot Cohort A (survey, genetic testing) Active Control 2 Interventions

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 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+

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

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Addressing barriers to care for African American men ... Patient navigation, an evidence-based intervention designed to eliminate barriers to care and improve health outcomes, is an effective approach ...

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Assessing the effect of patient navigator assistance for ... An enhanced patient navigation program demonstrates an improvement in health-related quality of life among Latino survivors of prostate and ...

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An intervention mapping approach to the development and ... An intervention mapping approach to the development and evaluation of a community-based prostate cancer early detection programme in Nigeria.