Initial testing of an educational approach to genetic services for families at risk of Lynch syndrome
Official title: A Randomized Controlled Pilot Trial of a Behavioral Intervention to Increase Uptake of Genetic Services Among Relatives at Risk of Lynch Syndrome
Run by University of Alabama at Birmingham · NCT07106359 · Data updated 2026-11-12
This pilot study tests whether an information letter alone or with a booklet helps at-risk relatives decide about pursuing genetic services for Lynch syndrome.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 185 (estimated) |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | August 31, 2027 |
| Study ends | October 31, 2027 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT07106359 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
English-speaking adults (18+) who are blood relatives of a Lynch syndrome patient and have not begun genetic counseling or testing.
✕Probably not a fit
Relatives who do not respond or who choose not to pursue genetic services may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a two-arm randomized pilot trial aimed at refining methods and materials for encouraging genetic counseling and testing among relatives of people with Lynch syndrome. Eligible participants are English-speaking adults who are blood relatives of a person diagnosed with Lynch syndrome and have not yet had genetic counseling or testing. Participants are randomized to receive either an information letter or an information letter plus a booklet, with surveys at baseline, 6 months, and an optional exit interview to collect feedback. The study will assess feasibility, recruitment, retention, and participants’ reactions to the education materials.
Why it matters
Potential benefit: If successful, the materials could improve engagement with genetic services and help at-risk relatives make informed decisions.
How similar studies have gone: Previous work has explored educational approaches to genetic counseling uptake; this is a pilot feasibility study to optimize methods for a fully powered trial.
Who can join: the full rules
Show full inclusion / 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)
Where it's running
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UAB
Birmingham, Alabama, United States Recruiting
Study contacts
- Study coordinator: Haoyang Yan, PhD
- Email: LSPilotStudy@uabmc.edu
- Phone: 205-914-2249
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.