NCT07106359

Initial Testing of a Behavioral Intervention About Genetic Services for Families at Risk of Lynch Syndrome

A Randomized Controlled Pilot Trial of a Behavioral Intervention to Increase Uptake of Genetic Services Among Relatives at Risk of Lynch Syndrome

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to see if our education materials help people at risk for Lynch syndrome decide about seeking genetic services. Untested relatives of patients with Lynch syndrome will be recruited to complete a baseline survey and will be randomized to receive either the an information letter or an information letter plus a booklet. Two follow-up surveys will be administered over the span of 6 months. Participants will also be invited to join an optional exit interview to provide feedback.

Detailed description

Lynch syndrome runs in families. It increases the risk of many types of cancer. Pre-test genetic counseling is an opportunity for at-risk people to determine whether genetic testing is right for them. Genetic testing looks for harmful changes in the genes known to cause Lynch syndrome. However, Lynch syndrome is underdiagnosed and uptake of genetic counseling and testing is low, missing opportunities for cancer prevention and early treatment. This study is a 2-arm randomized controlled pilot trial. We aim to recruit 48 relatives at risk of LS (from about 137 probands) and randomize them to receive either the an information letter or an information letter plus a booklet. Only one relative will be enrolled per family. The primary aim of this pilot trial is to evaluate and optimize feasibility of the trial methods and the education materials to prepare for a fully powered randomized controlled trial. A brief exit interview will be conducted at 6-months post-randomization to gather any feedback about the study methods. Reasons of those who refuse to participate or drop out of the study will be assessed throughout the study.

Conditions

• Cascade Testing
• Lynch Syndrome
• Decision Making
• Colorectal Cancer
• Uterine Cancer
• Cancer Prevention

Interventions

Type	Name	Description
BEHAVIORAL	Information Letter and Booklet	an information letter with a booklet for at-risk families highlighting implications of family history, testing considerations, steps for genetic testing, and potential costs.
BEHAVIORAL	Information Letter	an information letter with basic information about LS and implications of counseling and testing of LS, and a few websites for more information and locating genetic counselors.

Timeline

• Start date: 2025-09-15
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2025-08-06
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States