Peer Genetic Coaching for Prostate Cancer

Overseen By Amy Leader, DrPh, MPH

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Children, Anxiety, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial evaluates whether a network of peer genetic coaches is useful for addressing disparities in genetic testing and screening among African American men with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). While genetic testing has become central to prostate cancer care, African American men are less likely seek testing due to lack of awareness, cultural beliefs, financial limitations, fear of discrimination, and mistrust in the healthcare system. A network of peer genetic coaches may help address barriers, beliefs, and needs of African American men in the community and provide navigation to increase engagement in genetic testing.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Peer Genetic Coaching for Prostate Cancer?

The research highlights the importance of personalized genetic approaches in improving decision-making for prostate cancer treatment, suggesting that genetic coaching could enhance treatment outcomes by tailoring strategies to individual genetic profiles. ^{1 2 3 4 5}

Is Peer Genetic Coaching for Prostate Cancer safe for humans?

The research articles provided do not contain specific safety data for Peer Genetic Coaching or related interventions for prostate cancer or other conditions. ^{6 7 8 9 10}

How does Peer Genetic Coaching for Prostate Cancer differ from other treatments?

Peer Genetic Coaching for Prostate Cancer is unique because it involves personalized genetic counseling and testing to inform management and treatment decisions, which is not typically part of standard prostate cancer treatments. This approach focuses on understanding inherited genetic risks and tailoring screening and therapy based on individual genetic profiles, offering a more personalized treatment plan. ^{11 12 13 14 15}

Research Team

Amy Leader, DrPh, MPH

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

This trial is for African American men over 18 with metastatic prostate cancer or high-risk features, and those with a strong family history of certain cancers. Participants must be comfortable reading and speaking English. It excludes minors, individuals who struggle to understand consent, or have significant anxiety during the consent process.

Inclusion Criteria

Are African American

I am 18 years old or older.

Are able to read and speak English comfortably

Exclusion Criteria

Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process

I am under 18 years old.

Patients that do not meet the inclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Education

Peer genetic coaches undergo training and education on study

4-6 weeks

Coaching and Discussion

Patients receive an educational booklet and attend a discussion with a peer genetic coach

Up to 1 year

Follow-up

Participants are monitored for changes in decisional conflict, acceptability, and genetics knowledge

Up to 1 year

Treatment Details

Interventions

• Discussion
• Educational Intervention
• Training and Education

Trial Overview The study tests if peer genetic coaches can help overcome disparities in genetic testing among African American men with advanced prostate cancer by providing education, training, discussions, and navigation services to increase their engagement in genetic testing.

Participant Groups

Group I: Supportive care (training, education, discussion) Experimental Treatment 3 Interventions

AIM 1: Peer genetic coaches undergo training and education on study. AIM 2: Patients receive an educational booklet and attend a discussion with a peer genetic coach on study.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Findings from Research

A study of 776 prostate cancer patients identified eight specific genetic variations (SNPs) that can predict the risk of biochemical recurrence after radical prostatectomy, enhancing the understanding of individual risk factors.

Incorporating these genetic variations into a clinical model improved the predictive accuracy of biochemical recurrence from 85.1% to 89.0%, demonstrating that personalized genetic information can significantly enhance patient prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genome-wide detection of allelic genetic variation to predict biochemical recurrence after radical prostatectomy among prostate cancer patients using an exome SNP chip. Oh, JJ., Park, S., Lee, SE., et al.[2022]

In a study of 7636 Japanese prostate cancer patients, 2.9% were found to have pathogenic variants, significantly higher than the 0.8% in cancer-free controls, indicating a strong genetic component to prostate cancer risk.

Pathogenic variants in genes like BRCA2, HOXB13, and ATM were associated with increased prostate cancer risk, with BRCA2 variants showing an odds ratio of 5.65, suggesting that genetic testing could be crucial for early diagnosis and management of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Germline Pathogenic Variants in 7636 Japanese Patients With Prostate Cancer and 12 366 Controls. Momozawa, Y., Iwasaki, Y., Hirata, M., et al.[2022]

Patients with the BRCA2 999del5 mutation were diagnosed with prostate cancer at a younger age (69 years) and had more advanced disease stages and higher tumor grades compared to non-carriers, indicating a more aggressive form of cancer.

Carrying the BRCA2 999del5 mutation significantly increased the risk of dying from prostate cancer, with a hazard ratio of 3.42, highlighting the mutation's strong association with poor prognosis and rapid disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cancer progression and survival in BRCA2 mutation carriers. Tryggvadóttir, L., Vidarsdóttir, L., Thorgeirsson, T., et al.[2022]

Genomic biomarkers, such as TMPRSS2:ERG gene fusion and PTEN loss, are becoming important tools for predicting prostate cancer outcomes and therapeutic responses, enhancing personalized treatment strategies.

Several commercially available gene panels, including Prolaris and Oncotype DX, have shown promise in estimating disease outcomes alongside traditional clinical assessments, although their widespread use is still developing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genomic Predictors of Outcome in Prostate Cancer. Boström, PJ., Bjartell, AS., Catto, JW., et al.[2022]

The Genetic Testing Station (GTS) model significantly improved germline testing completion rates for men with prostate cancer, with 83% of 713 referred patients completing testing within 60 days, compared to a much lower rate before GTS implementation.

Despite the effectiveness of GTS in increasing access to testing, racial disparities persist, as Black patients had lower odds of completing testing compared to White patients, highlighting the need for targeted interventions to address these inequities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Telehealth Genetic Testing Station to Deliver Germline Testing for Men With Prostate Cancer. Kwon, DH., Gordon, KM., Tong, B., et al.[2023]

The C-MOnGene study implemented a collaborative oncogenetic model that successfully doubled the annual number of patients receiving genetic counseling for hereditary breast and ovarian cancer (HBOC) within three years.

The model not only reduced the waiting time for test results but also enhanced patient understanding of breast cancer risk through group counseling, leading to high satisfaction rates among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Collaborative Model to Implement Flexible, Accessible and Efficient Oncogenetic Services for Hereditary Breast and Ovarian Cancer: The C-MOnGene Study. Lapointe, J., Dorval, M., Chiquette, J., et al.[2021]

A centralized telephone genetic counseling service in Australia has improved access to BRCA1/2 testing for women with high-grade serous ovarian cancer, allowing oncologists to refer patients more efficiently and reducing the need for travel, especially for those in rural areas.

Oncologists found the service to be timely and convenient, although they emphasized the need for in-person counseling for patients who received positive BRCA1/2 results, highlighting areas for improvement in communication between the service and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologists' perspectives of telephone genetic counseling to facilitate germline BRCA1/2 testing for their patients with high-grade serous ovarian cancer. Hemming, P., Kaur, R., Meiser, B., et al.[2021]

Cascade testing for cancer genetic risk is essential, but barriers like family communication and coping with genetic risk can hinder its effectiveness.

Implementing a peer support model in clinical trials for BRCA1/2-related testing shows promise in improving family communication and functioning, making it easier for families to understand and adapt to genetic risk information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving our model of cascade testing for hereditary cancer risk by leveraging patient peer support: a concept report. O'Neill, SC., Hamilton, JG., Conley, CC., et al.[2021]

A pilot study involving 125 members referred for Hereditary Breast and Ovarian Cancer (HBOC) genetic counseling showed that using a patient navigator increased the rate of appointment attendance to 44% compared to 31% in the usual care group.

The patient navigator approach significantly reduced the time to appointment, with over 80% of Navigator-assisted members seen within three months, compared to only 32% in the usual care group, indicating a potential strategy to improve access to genetic counseling services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing utilization of cancer genetic counseling services using a patient navigator model. Rahm, AK., Sukhanova, A., Ellis, J., et al.[2019]

A web-based educational tool significantly increased knowledge and feelings of empowerment regarding genetic testing among 305 patients, regardless of their health literacy levels, indicating its effectiveness in educating patients before genetic counseling.

The tool may help address the shortage of trained genetic providers by streamlining the delivery of genetic services, as it was shown to enhance patient understanding without altering attitudes towards testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Tool to Automate Portions of Pretest Genetic Counseling for Inherited Cancer. Cragun, D., Weidner, A., Tezak, A., et al.[2021]

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]

In a study of 200 men, 5.5% were found to have mutations related to prostate cancer, primarily in DNA repair genes, indicating the potential for targeted therapies based on genetic profiles.

A family history of breast cancer was significantly linked to mutation status, suggesting that detailed family histories are crucial for identifying men who may benefit from genetic evaluation and personalized cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inherited Mutations in Men Undergoing Multigene Panel Testing for Prostate Cancer: Emerging Implications for Personalized Prostate Cancer Genetic Evaluation. Giri, VN., Obeid, E., Gross, L., et al.[2022]

A consensus was reached among experts that genetic testing for prostate cancer (PCA) should include specific genes like HOXB13 for hereditary PCA and BRCA1/2 for hereditary breast and ovarian cancer, emphasizing the importance of shared decision-making in testing.

The conference highlighted the need for genetic testing in all men with metastatic castration-resistant PCA, regardless of family history, to better inform prognosis and targeted therapy options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Genetic Testing for Inherited Prostate Cancer Risk: Philadelphia Prostate Cancer Consensus Conference 2017. Giri, VN., Knudsen, KE., Kelly, WK., et al.[2023]

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]

In a study of 184 prostate cancer patients, offering germline testing in-office resulted in the highest response rate (66%) and the shortest time to testing (significantly faster than telephone referrals, which had a 17% response rate and took an average of 103 days).

The method of referral significantly influenced both the likelihood of patients receiving germline testing and the time it took to complete the testing, highlighting the importance of in-office offers for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the most effective way to ensure that patients successfully undergo germline testing for prostate cancer? Ahlborn, D., Staff, I., McLaughlin, T., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Genome-wide detection of allelic genetic variation to predict biochemical recurrence after radical prostatectomy among prostate cancer patients using an exome SNP chip. [2022]

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

Germline Pathogenic Variants in 7636 Japanese Patients With Prostate Cancer and 12 366 Controls. [2022]

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

Prostate cancer progression and survival in BRCA2 mutation carriers. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Genomic Predictors of Outcome in Prostate Cancer. [2022]

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

Implementation of a Telehealth Genetic Testing Station to Deliver Germline Testing for Men With Prostate Cancer. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Collaborative Model to Implement Flexible, Accessible and Efficient Oncogenetic Services for Hereditary Breast and Ovarian Cancer: The C-MOnGene Study. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Oncologists' perspectives of telephone genetic counseling to facilitate germline BRCA1/2 testing for their patients with high-grade serous ovarian cancer. [2021]

8. Poland pubmed.ncbi.nlm.nih.gov

Improving our model of cascade testing for hereditary cancer risk by leveraging patient peer support: a concept report. [2021]

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

Increasing utilization of cancer genetic counseling services using a patient navigator model. [2019]

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

A Web-Based Tool to Automate Portions of Pretest Genetic Counseling for Inherited Cancer. [2021]

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

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

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

Inherited Mutations in Men Undergoing Multigene Panel Testing for Prostate Cancer: Emerging Implications for Personalized Prostate Cancer Genetic Evaluation. [2022]

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

Role of Genetic Testing for Inherited Prostate Cancer Risk: Philadelphia Prostate Cancer Consensus Conference 2017. [2023]

14. Canada pubmed.ncbi.nlm.nih.gov

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

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

What is the most effective way to ensure that patients successfully undergo germline testing for prostate cancer? [2023]