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Recruiting NCT07106359

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

No phase Interventional Cascade Testing Lynch Syndrome Decision Making Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Information Letter and Booklet, Information Letter.
Who it may be relevant to
Registry conditions: Cascade Testing, Lynch Syndrome, Decision Making, Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Feasibility (recruitment and retention rates, completeness of assessment data) [Time frame: (recruitment) baseline, 1-month and 6-months post-randomization]
  • Use and attitudes towards the education materials [Time frame: 1-month post-randomization (may also include in 6-month post-randomization]
  • Scheduling and attendance of pre-test genetic counseling and/or genetic testing [Time frame: 6-months post-randomization]
Secondary outcome measures (1)
  • Scheduling and attendance of pre-test genetic counseling and/or genetic testing [Time frame: 1-month post-randomization]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • UAB — Birmingham

Identifiers

NCT: NCT07106359 · IRB-300014784 · R00CA277584

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗