Genetic Education for Prostate Cancer

(ENGAGE Trial)

Not yet recruiting at 1 trial location
MS
Overseen ByMarc Schwartz
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Georgetown University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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

I was diagnosed with prostate cancer at least 6 months ago.
Have internet access via smartphone, tablet or computer
I meet the guidelines for genetic testing for inherited cancer risk.
See 6 more

Exclusion Criteria

Do not speak English
Unable to access the Internet
I have had genetic testing or declined it after counseling for hereditary cancer risk.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

6 months
Ongoing engagement through digital or print materials

Follow-up

Participants are monitored for engagement with genetic education and uptake of genetic testing, as well as psychosocial outcomes and decision-making processes.

6 months
1-month and 6-month surveys

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

Group I: Print Genetic Education plus Streamlined Genetic Testing (Print+)Experimental Treatment1 Intervention
Group II: Digital Guide Genetic Education Plus Streamlined Genetic Testing (DG+)Experimental Treatment1 Intervention
Group III: Enhanced Usual Care (EUC)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials
355
Recruited
142,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Rutgers University

Collaborator

Trials
127
Recruited
2,814,000+

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.

Guidelines 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 ...

The 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 ...