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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether peer genetic coaches can help African American men with metastatic prostate cancer learn more about genetic testing. Genetic testing plays a crucial role in prostate cancer care, but many African American men encounter barriers such as cultural beliefs and mistrust of the healthcare system. The trial seeks to determine if trained peers can bridge these gaps and encourage more men to undergo testing. Suitable candidates for this trial include African American men with metastatic prostate cancer or a strong family history of cancer.

As a Phase 2 trial, this research focuses on assessing the effectiveness of the peer coaching approach in an initial, smaller group, offering participants a chance to contribute to significant advancements in prostate cancer care.

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 prior data suggests that this protocol is safe for addressing disparities in genetic testing among African American men with metastatic prostate cancer?

Research has shown that peer genetic coaching is generally safe and well-tolerated. Studies have found that using peer educators to encourage genetic testing for prostate cancer in Black men can be effective without causing harm. These educational sessions offer information and support, which are non-invasive and carry minimal risk. Participants typically report positive experiences, highlighting the benefits without significant negative effects. This suggests the approach is safe for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Peer Genetic Coaching for Prostate Cancer trial because it offers a fresh approach to patient care by focusing on personalized education and support. Unlike standard treatments that primarily revolve around medical and surgical interventions, this approach leverages peer support to help patients understand their genetic risks and treatment options. By providing one-on-one discussions with trained peer coaches, patients receive tailored educational materials and guidance, potentially leading to better-informed decisions about their health. This method aims to empower patients with knowledge and emotional support, which could enhance their overall treatment experience and outcomes.

What evidence suggests that this trial's interventions could be effective for increasing genetic testing among African American men with metastatic prostate cancer?

Research has shown that peer support can simplify understanding genetic testing. One study demonstrated that men who learned from peer educators grasped complex medical information more effectively. Another study found that peer education helped Black men learn about genetic testing for prostate cancer within their communities. This trial will employ peer genetic coaches to offer supportive care, including training, education, and discussion, to address challenges like lack of awareness and mistrust in healthcare. By using peer coaches, the trial aims to make genetic testing more accessible and acceptable to African American men with prostate cancer. ^{1 2 3 4 5}

Who Is on the Research Team?

Amy Leader, DrPh, MPH

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

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 a man with advanced prostate cancer or have a strong family history of certain cancers.

I am a man with prostate cancer experience and have undergone genetic counseling or testing. I also have experience in peer education or navigation.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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 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]

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]

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 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0027968425000409

Utilizing peer educators to increase genetic testing for ... The peer educators were positively able to impact males' understanding of complex medical information. Males in the intervention group were ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40447525/

Utilizing peer educators to increase genetic testing for ... We aimed to evaluate the impact of a peer-based educational intervention about PCa genetic testing for Black males in a community setting.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05627219

Study Details | NCT05627219 | Extending Prostate Genetic ... Patient-related outcomes will include change in decisional conflict for genetic counseling, acceptability/attitude toward genetic counseling and testing, and ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.6_suppl.059

Impact of provider education on prostate cancer genetic ... Prostate cancer genetics referrals increased 118% following educational presentations to urologists, medical oncologists, and nurse navigators.

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-08846

Peer Genetic Coaches for Enhancing Genetic Testing ... This study evaluates whether a network of peer genetic coaches is useful for addressing disparities in genetic testing and screening among African American ...