Peer Genetic Coaching for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Overseen byAmy Leader, DrPh, MPH
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Thomas Jefferson University
Disqualifiers: Children, Anxiety, others
No Placebo Group
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.
12345Is 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.
678910How 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.
1112131415Eligibility 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
+2 more
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
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Supportive care (training, education, discussion)Experimental Treatment3 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphia, PA
Loading ...
Who Is Running the Clinical Trial?
Thomas Jefferson UniversityLead Sponsor
References
Genome-wide detection of allelic genetic variation to predict biochemical recurrence after radical prostatectomy among prostate cancer patients using an exome SNP chip. [2022]Genetic variations among prostate cancer patients who underwent radical prostatectomies were evaluated to predict biochemical recurrence, and used to develop a clinical-genetic model that combines data on clinicopathological factors of prostate cancer and individual genetic variations.
Germline Pathogenic Variants in 7636 Japanese Patients With Prostate Cancer and 12 366 Controls. [2022]Genetic testing has been conducted in patients with prostate cancer (PCa) using multigene panels, but no centralized guidelines for genetic testing exist. To overcome this limitation, we investigated the demographic and clinical characteristics of patients with pathogenic variants.
Prostate cancer progression and survival in BRCA2 mutation carriers. [2022]Mutations in the BRCA2 gene are associated with an increased risk of prostate cancer, but it is not known whether they are associated with progression of the disease. We compared prostate cancer-specific survival, disease stage, and tumor grade between prostate cancer patients carrying the Icelandic BRCA2 999del5 founder mutation and noncarriers.
Genomic Predictors of Outcome in Prostate Cancer. [2022]Given the highly variable behavior and clinical course of prostate cancer (PCa) and the multiple available treatment options, a personalized approach to oncologic risk stratification is important. Novel genetic approaches offer additional information to improve clinical decision making.
Implementation of a Telehealth Genetic Testing Station to Deliver Germline Testing for Men With Prostate Cancer. [2023]Germline testing for men with prostate cancer (PCa) poses numerous implementation barriers. Alternative models of care delivery are emerging, but implementation outcomes are understudied. We evaluated implementation outcomes of a hybrid oncologist- and genetic counselor-delivered model called the genetic testing station (GTS) created to streamline testing and increase access.
A Collaborative Model to Implement Flexible, Accessible and Efficient Oncogenetic Services for Hereditary Breast and Ovarian Cancer: The C-MOnGene Study. [2021]Medical genetic services are facing an unprecedented demand for counseling and testing for hereditary breast and ovarian cancer (HBOC) in a context of limited resources. To help resolve this issue, a collaborative oncogenetic model was recently developed and implemented at the CHU de Québec-Université Laval; Quebec; Canada. Here, we present the protocol of the C-MOnGene (Collaborative Model in OncoGenetics) study, funded to examine the context in which the model was implemented and document the lessons that can be learned to optimize the delivery of oncogenetic services. Within three years of implementation, the model allowed researchers to double the annual number of patients seen in genetic counseling. The average number of days between genetic counseling and disclosure of test results significantly decreased. Group counseling sessions improved participants' understanding of breast cancer risk and increased knowledge of breast cancer and genetics and a large majority of them reported to be overwhelmingly satisfied with the process. These quality and performance indicators suggest this oncogenetic model offers a flexible, patient-centered and efficient genetic counseling and testing for HBOC. By identifying the critical facilitating factors and barriers, our study will provide an evidence base for organizations interested in transitioning to an oncogenetic model integrated into oncology care; including teams that are not specialized but are trained in genetics.
Oncologists' perspectives of telephone genetic counseling to facilitate germline BRCA1/2 testing for their patients with high-grade serous ovarian cancer. [2021]Poly ADP ribose polymerase (PARP) inhibitors offer a survival advantage to women with high-grade serous ovarian cancer who have a germline BRCA1/2 pathogenic variant (PV). Yet, rates of genetic testing among this population have remained persistently low. A national, centralized telephone genetic counseling service was established in January 2016 in Australia to improve access to genetic services and facilitate BRCA1/2 testing for this population to inform treatment. Medical oncologists can refer their patients with high-grade serous ovarian cancer to this service for genetic testing. This study aimed to explore oncologists' experiences of using this telephone genetic counseling service for their patients with high-grade serous ovarian cancer. A qualitative approach using semi-structured telephone interviews was undertaken with Australian oncologists who had referred patients to the telephone genetic counseling service. Sixteen oncologists participated and described referring patients to the telephone genetic counseling service due to the timeliness of obtaining a genetic counseling appointment and BRCA1/2 test results. They also reported this service offered convenience for patients living in regional or rural areas who then did not have to travel for an appointment with a clinical genetics service. Many oncologists noted the importance of in-person genetic counseling for patients who received positive BRCA1/2 results. Areas for improvement identified by the oncologists related to communication issues between the service and the patient. Overall, findings suggest that oncologists perceived telephone genetic counseling as an acceptable and useful healthcare service for patients with high-grade serous ovarian cancer. Moreover, they perceived telephone genetic counseling to be efficient, delivering convenient genetic counseling to patients.
Improving our model of cascade testing for hereditary cancer risk by leveraging patient peer support: a concept report. [2021]Consensus and evidence suggest that cascade testing is critical to achieve the promise of cancer genetic testing. However, barriers to cascade testing include effective family communication of genetic risk information and family members' ability to cope with genetic risk. These barriers are further complicated by the developmental needs of unaffected family members during critical windows for family communication and adaptation. Peer support could address these barriers. We provide two illustrative examples of ongoing BRCA1/2-related clinical trials that apply a peer support model to improve family communication and functioning. Peer support can augment currently available genetic services to facilitate adjustment to and effective use of cancer genetic risk information. Importantly, this scalable approach can address the presence of cancer risk within families across multiple developmental stages. This applies a family-centered perspective that accommodates all potentially at-risk relatives. This peer support model can be further applied to emerging topics in clinical genetics to expand reach and impact.
Increasing utilization of cancer genetic counseling services using a patient navigator model. [2019]Rarely has utilization of genetic counseling for Hereditary Breast and Ovarian Cancer (HBOC) been studied separately from utilization of testing. At Kaiser Permanente Colorado, consistently only 30% of all members referred for HBOC attend genetic counseling. To increase the volume of genetic counseling appointments, a patient navigator approach was pilot tested in a randomized-controlled trial over 3 months. A total of 125 members were referred for HBOC genetic counseling (55 randomized to PN, 70 randomized to usual care). Utilization of referrals for Navigator-assisted members was 44%, compared to 31% in the usual care arm (p=0.16). The patient navigator significantly decreased time to appointment, with over 80% of Navigator-assisted members seen for genetic counseling less than three months from referral date, compared to 32% in usual care (p=0.002). patient navigator assistance shortens time from referral to appointment for HBOC genetic counseling, and may increase utilization of such services.
A Web-Based Tool to Automate Portions of Pretest Genetic Counseling for Inherited Cancer. [2021]Increasing demand for genetic testing for inherited cancer risk coupled with a shortage of providers trained in genetics highlight the potential for automated tools embedded in the clinic process to meet this demand. We developed and tested a scalable, easy-to-use, 12-minute web-based educational tool that included standard pretest genetic counseling elements related to panel-based testing for multiple genes associated with cancer risk.
Hereditary cancer risk assessment and genetic testing in the community urology practice setting. [2022]To evaluate the feasibility of integrating a hereditary cancer risk assessment (HCRA) process in the community urology practice setting for patients with prostate cancer (PCa).
Inherited Mutations in Men Undergoing Multigene Panel Testing for Prostate Cancer: Emerging Implications for Personalized Prostate Cancer Genetic Evaluation. [2022]Multigene panels are commercially available for the evaluation of prostate cancer (PCA) predisposition, which necessitates tailored genetic counseling (GC) for men. Here we describe emerging results of Genetic Evaluation of Men, prospective multigene testing study in PCA to inform personalized genetic counseling, with emerging implications for referrals, cancer screening, and precision therapy.
Role of Genetic Testing for Inherited Prostate Cancer Risk: Philadelphia Prostate Cancer Consensus Conference 2017. [2023]Purpose Guidelines are limited for genetic testing for prostate cancer (PCA). The goal of this conference was to develop an expert consensus-driven working framework for comprehensive genetic evaluation of inherited PCA in the multigene testing era addressing genetic counseling, testing, and genetically informed management. Methods An expert consensus conference was convened including key stakeholders to address genetic counseling and testing, PCA screening, and management informed by evidence review. Results Consensus was strong that patients should engage in shared decision making for genetic testing. There was strong consensus to test HOXB13 for suspected hereditary PCA, BRCA1/2 for suspected hereditary breast and ovarian cancer, and DNA mismatch repair genes for suspected Lynch syndrome. There was strong consensus to factor BRCA2 mutations into PCA screening discussions. BRCA2 achieved moderate consensus for factoring into early-stage management discussion, with stronger consensus in high-risk/advanced and metastatic setting. Agreement was moderate to test all men with metastatic castration-resistant PCA, regardless of family history, with stronger agreement to test BRCA1/2 and moderate agreement to test ATM to inform prognosis and targeted therapy. Conclusion To our knowledge, this is the first comprehensive, multidisciplinary consensus statement to address a genetic evaluation framework for inherited PCA in the multigene testing era. Future research should focus on developing a working definition of familial PCA for clinical genetic testing, expanding understanding of genetic contribution to aggressive PCA, exploring clinical use of genetic testing for PCA management, genetic testing of African American males, and addressing the value framework of genetic evaluation and testing men at risk for PCA-a clinically heterogeneous disease.
Germline testing for prostate cancer: community urology perspective. [2020]In an attempt to better understand how community urology practices would begin to incorporate hereditary testing in prostate cancer patients, we developed an eight-question on line survey to identify current testing patterns, utilization of genetic counseling and barriers that practices face. Fifty-two large community urology practices participated. A total of 32/52 (63%) of the responders were already offering testing to select patients. The big hurdles practices were concerned when initiating testing were fear of medical/legal liability (22%), concerns over reimbursement and out of pocket patient expense (20%) and the complexity, time and difficulty to enter a complete family history/pedigree into the EHR (18%).
What is the most effective way to ensure that patients successfully undergo germline testing for prostate cancer? [2023]We sought to identify the most effective way to refer patients with prostate cancer to germline testing.