Health TrialsbyHealthPanel

Expanding Genetic Access for Prostate Cancer Survivors

ConditionsProstate Cancer PatientsHereditary CancerGenetic Testing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-80
SponsorGeorgetown University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-80 years of age

At least 6-months post diagnosis with prostate cancer

Have not had genetic testing for hereditary cancer

Have received care at one of the participating sites in the prior five years

Disqualifiers

Do not speak English

Unable to access the Internet

Have previously undergone germline genetic testing for hereditary cancer risk or previously had genetic counseling (GC) and declined genetic testing (GT)

Are unable to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Print Genetic Education Guide

    Behavioral

    Consists of clinical letter, genetic testing kit, and a print genetic education guide along with streamlined access to genetic testing for hereditary cancer risk.

  • Digital Guide Genetic Education Guide

    Behavioral

    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.

  • Enhanced Usual Care

    Behavioral

    Consists of clinical letter and recommendation/referral to schedule a genetic counseling session.

Treatment groups

500 Participants
are divided into 3 treatment groups
Group A: Enhanced Usual Care (EUC)Active comparator 1 intervention
Group B: Print Genetic Education plus Streamlined Genetic Testing (Print+)Experimental treatment 1 intervention
Group C: Digital Guide Genetic Education Plus Streamlined Genetic Testing (DG+)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Uptake of Germline Genetic Testing

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
6-Months
2

Survey Assessment of Impact of DG+ vs. Print+ vs. EUC

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
1-Month and 6-Month surveys
3

Survey Assessment of Mediators and Moderators of Efficacy

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
Baseline, 1-Month and 6-Month surveys

Secondary outcomes

1

Survey Assessment of Engagement with Genetic Education

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.

Time frame
1-Month Survey

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgetown University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Rutgers University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: