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

The University of Alabama at Birmingham

Status: Invitation-only

Conditions: Cascade Testing; Decision Making; Uterine Cancer; Lynch Syndrome; Cancer Prevention; Colorectal Cancer

Treatments: Behavioral: Information Letter; Behavioral: Information Letter and Booklet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07106359

IRB-300014784

R00CA277584 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 185 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Probands Inclusion Criteria:

• English speaking
• at least 18 years old
• have had genetic testing for Lynch syndrome (LS)
• do not have a condition that would interfere with their ability to provide informed consent and complete study activities (e.g., cognitive dysfunction evaluated using clinical judgment during screening)

Clinical Trial Participants Inclusion Criteria:

• English-speaking
• at least 18 years old
• a blood relative of a patient who was diagnosed with LS
• potentially at risk for LS
• have not scheduled or had pre-test genetic counseling or genetic testing for LS
• do not have a personal history of a cancer (excluding non-melanoma skin cancer)
• do not have a condition that would interfere with their ability to provide informed consent and complete study activities (e.g., cognitive dysfunction evaluated using clinical judgment during screening)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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185 participants in 2 patient groups

Information Letter

Active Comparator group

Description:

This arm provides an information letter about Lynch syndrome and genetic services.

Treatment:

Behavioral: Information Letter

Information Letter and Booklet

Experimental group

Description:

This arm provides an information letter with a booklet about Lynch syndrome and genetic services.

Treatment:

Behavioral: Information Letter and Booklet