Genetic Education for Prostate Cancer
(ENGAGE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether a digital guide, a print guide, or usual care better assists prostate cancer survivors in learning about and requesting genetic testing for hereditary cancer risk. Researchers will divide participants into three groups, each receiving different educational materials and support for genetic testing. The study will examine how these methods influence decision-making and overall well-being. Men diagnosed with prostate cancer at least six months ago, who have not undergone genetic testing, and who can access the internet are ideal candidates for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance educational resources for prostate cancer survivors.
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 seems focused on genetic education and testing, so it's unlikely that your medications will be affected.
What prior data suggests that these methods are safe for genetic education and testing?
Research has shown that digital guides for learning about genetics are generally safe and well-liked. In a review of 87 studies, 84% of patients using digital tools reported positive outcomes, such as better understanding and improved mental well-being. This indicates that the digital guide in this trial is likely safe and effective for participants.
For the print guide, no specific safety concerns have been mentioned. However, genetic testing and educational materials, like those in the print guide, are commonly used in medical practice and are usually well-tolerated. The National Comprehensive Cancer Network recommends these materials for patients with prostate cancer, providing some assurance of their safety.
Overall, both the digital and print guides appear to be safe options for learning about genetic testing and the risks related to prostate cancer.12345Why are researchers excited about this trial?
Researchers are excited about the Genetic Education for Prostate Cancer trial because it explores innovative ways to educate patients about their genetic risk for cancer. Unlike traditional genetic counseling, the Digital Guide and Print+ arms provide comprehensive information through digital and print formats, making it more accessible and potentially less intimidating. These guides offer streamlined genetic testing options, allowing participants to understand their risks and make informed decisions more conveniently. By integrating videos, infographics, and real-time support, these new methods could enhance patient engagement and understanding, paving the way for more personalized cancer risk management.
What evidence suggests that this trial's methods could be effective for increasing genetic education and testing among prostate cancer survivors?
Studies have shown that genetic testing can greatly assist prostate cancer patients by guiding treatment choices and clarifying family risk. This trial will compare various educational approaches to facilitate genetic testing. Participants in the Digital Guide Genetic Education Plus Streamlined Genetic Testing (DG+) arm will receive digital tools, which research indicates can enhance understanding and increase the likelihood of choosing genetic testing. Specifically, a review found that 84% of patients using digital tools reported improved knowledge and well-being. The Print Genetic Education plus Streamlined Genetic Testing (Print+) arm will offer print guides with detailed information about genetic risk and testing options, similar to traditional genetic counseling. Both digital and print methods aim to make genetic testing more accessible and understandable. The Enhanced Usual Care (EUC) arm will serve as a comparator, providing standard information and support.14678
Are You a Good Fit for This Trial?
This trial is for people who have survived prostate cancer. Participants should be interested in learning about their genetic risk for cancer and willing to receive educational materials and possibly undergo genetic testing.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants are randomized into one of three groups: Enhanced Usual Care (EUC), Print Genetic Education plus Streamlined Genetic Testing (Print+), or Digital Guide Genetic Education Plus Streamlined Genetic Testing (DG+). Each group receives genetic education and has the opportunity to request genetic testing.
Follow-up
Participants are monitored for engagement with genetic education and uptake of genetic testing, as well as psychosocial outcomes and decision-making processes.
What Are the Treatments Tested in This Trial?
Interventions
- Digital Guide Genetic Education Guide
- Enhanced Usual Care
- Print Genetic Education Guide
Trial Overview
The study compares three ways of providing genetic education: a digital guide, a printed guide, or enhanced usual care. Participants are randomly assigned to one group to see which method best encourages them to learn about genetics and get tested.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants in the Print+ arm will receive a clinical letter from the institution's clinical genetics program along with a copy of the print education guide and a genetic testing kit. The print guide provides detailed information regarding risk for hereditary cancer and options for genetic testing comparable to the information conveyed in traditional genetic counseling (GC). Information is conveyed through a combination of text, infographics, and images. Print+ participants who wish to proceed directly to GT can request an out-of-pocket cost estimate and then return the GT kit directly to the testing lab. Results will be shared with the participant, their oncologist and tailored per the result. Participants who indicate that they are unsure or do not want GT will be encouraged to discuss their risk and GT options with their oncology provider and to schedule a GC appointment with the clinic.
Participants in the DG+ arm will receive a clinical letter from the institution's clinical genetics program with a link to the RA along with a genetic testing kit. The fully HIPAA-compliant DG will provide comparable educational information to traditional genetic counseling (GC) but in a streamlined and tailored manner including video, education and decision support, patient testimonial and answers to questions in real-time. Participants will be informed that they may speak to a genetic risk specialist free of charge. Participants who wish to proceed directly to GT can indicate this within the DG. They will be provided with a GT out-of-pocket cost estimate before returning the GT kit. Results will be shared with the participant, their oncologist and tailored per the result. Participants who indicate that they are unsure or do not want GT will be encouraged by RA to discuss their risk and GT options with their oncology provider and to schedule a GC appointment with the clinic.
Participants in the EUC arm will be mailed a clinical letter. The letter sent to EUC participants will inform them of their own and their family's potential risk for carrying a pathogenic variant (PV) related to hereditary cancer. The letter will emphasize their eligibility for GT, include a recommendation to consider scheduling a GC appointment to obtain more information, and include a link to the Rutgers Cancer Institute or LCCC high-risk clinic website. The study team will help facilitate GT when requested by the participant. Results will be shared with the participant, their oncologist and tailored per the result.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Georgetown University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Rutgers University
Collaborator
Citations
Expanding Genetic Access for Prostate Cancer Survivors
The goal of this study is to increase genetic education and genetic testing for hereditary cancer risk among prostate cancer survivors.
TARGET: A Randomized, Noninferiority Trial of a Pretest ...
Germline genetic testing (GT) is important for prostate cancer (PCA) management, clinical trial eligibility, and hereditary cancer risk.
Prostate Cancer Foundation Launches Guide on Genetic ...
The new resource covers what somatic and germline testing are, how they help guide treatment decisions, how to understand and act on test ...
Video Education Is an Acceptable Alternative to Pretest ...
This paper shows that VE is a viable option, which may increase GT uptake for patients with breast, ovarian, pancreatic, or metastatic prostate cancer.
5.
onclive.com
onclive.com/view/guidelines-recommend-widespread-genetic-testing-for-metastatic-prostate-cancer-associated-familyGuidelines Recommend Widespread Genetic Testing for ...
What prostate cancer-specific recommendations should be considered on the basis of genetic results? What is optimal informed consent for ...
Germline testing and genetic counselling in prostate cancer
These data show that multiple genes linked with a spectrum of hereditary cancer syndromes are associated with varying degrees of prostate cancer risk, disease ...
7.
facingourrisk.org
facingourrisk.org/research-clinical-trials/study/360/the-prostate-cancer-genetic-risk-and-equitable-screening-study-progressThe Prostate Cancer, Genetic Risk, and Equitable ...
About the Study. This study is testing using a person's genetics to guide screening that can make prostate cancer testing more accurate and reduce harms.
New Guide Helps Patients Navigate Genetic Testing for ...
New Guide Helps Patients Navigate Genetic Testing for Advanced Prostate Cancer · The basics of DNA, genes, and gene alterations · How both tests work, and why ...
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