A Randomized Controlled Pilot Trial of a Behavioral Intervention to Increase Uptake of Genetic Services Among Relatives at Risk of Lynch Syndrome
University of Alabama at Birmingham
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.
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 re…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- BehavioralInformation 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.
- BehavioralInformation 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.
Location
- UABBirmingham, Alabama