Print Genetic Education Guide
BehavioralConsists of clinical letter, genetic testing kit, and a print genetic education guide along with streamlined access to genetic testing for hereditary cancer risk.
Other names: Print+
NCT Number: NCT07618520
The goal of this study is to increase genetic education and genetic testing for hereditary cancer risk among prostate cancer survivors. The study will:
Test the effectiveness of a digital guide (DG+) vs. print guide (Print+) vs. enhanced usual care (EUC) on engagement in genetic education and uptake of genetic testing.
Evaluate the impact of the DG+ vs. Print+ vs. EUC on the process that participants use to make decisions and evaluate effects on well-being (also called psychosocial outcomes).
Explore the ways (methods) that influence how participants experience the intervention.
The main questions this study aims to answer are: which group - the digital guide (DG+) group, print (Print+) group or the EUC group - is more likely to request genetic testing and which group is more likely to get (engage with) genetic education.
Participants will be randomly assigned to either the digital guide (DG+) group, the print guide (Print+) group or EUC group. Each group will receive genetic education and have an opportunity to request genetic testing. Researchers will compare the three groups to determine which is most most likely to complete genetic testing (GT) and which group engages more with genetic education.
Trial opening soon.
Get Notified18 year–80 year
Male
Interventional
Not applicable
Georgetown University Medical Center/Lombardi Comprehensive Cancer Center, Washington D.C., District of Columbia, United States
Research Design and Methods:
This study will employ a 3-arm parallel group randomized controlled trial to evaluate the efficacy of the DG+ and Print+ interventions compared to EUC among 500 prostate cancer survivors who meet the National Comprehensive Cancer Network's guidelines for genetic referral. Primary outcomes will be engagement with genetic education and uptake of genetic testing (Aim 1). The investigators will also evaluate the impact of the interventions on psychosocial and decision quality outcomes (Aim 2) and evaluate mediators and moderators of intervention impact (Aim 3).
Research Procedures:
The design for this study is a 3-arm parallel group trial. Randomization is at the patient level. The investigators will recruit eligible cancer survivors who will be randomized by computer to enhanced usual care (EUC), DG+ or Print+ in a 1:2:2 ratio - with 100 participants randomized to EUC (control) arm and 200 randomized the each of the intervention arms (DG+ and Print+).
The investigators will utilize the EHRs at our participating sites to identify prostate cancer survivors who have not been tested despite meeting GT eligibility criteria. Participants will be ascertained from 1) Georgetown Lombardi Comprehensive Cancer Center (LCCC) and MedStar Washington Cancer Institute (MWCI) in DC and 2) Rutgers' Cancer Institute (in New Brunswick and at University Hospital Newark) including RWJ Barnabas Health community oncology sites. Participants will be men who have a history of prostate cancer, are at least six-months post-diagnosis, and have received care at one of the participating sites in the prior five years. There is no limit on the years since diagnosis as genetic testing (GT) can guide treatment decisions and provide opportunities for cascade testing to guide screening and prevention in at-risk relatives.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Consists of clinical letter, genetic testing kit, and a print genetic education guide along with streamlined access to genetic testing for hereditary cancer risk.
Other names: Print+
Consists of clinical letter, genetic testing kit, and access to a genetic education digital guide along with streamlined access to genetic testing for hereditary cancer risk.
Other names: DG+
Consists of clinical letter and recommendation/referral to schedule a genetic counseling session.
Other names: EUC
Time frame: 6-Months
As captured via internal RedCap form for the number or count of participants who opt for genetic testing during the six-month study period. The investigators will compare the three study arms to evaluate efficacy of the DG+ and Print+ interventions compared to EUC and to each other.
Time frame: 1-Month and 6-Month surveys
Evaluate the impact of the DG+ vs. Print+ vs. EUC on informed decision-making and psychosocial outcomes via survey measures of related constructs at 1-month and 6-month surveys. Multiple scales are used to measure this outcome and each scale has a unique scoring system.
Time frame: Baseline, 1-Month and 6-Month surveys
Explore potential mechanisms by assessing mediators and moderators of efficacy via survey measures of related constructs at baseline, 1-month and 6-month surveys. Multiple scales are used to measure this outcome and each scale has a unique scoring system.
Time frame: 1-Month Survey
Engagement with genetic education/counseling via survey measures of related constructs at 1-month survey. Multiple scales are used to measure this outcome and each scale has a unique scoring system.
Contact information is provided by the study sponsor or research team.
Georgetown University
Other
Expanding Genetic Access and Guided Education for Prostate Cancer Survivors
Acronym: ENGAGE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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