Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment185 (estimated)
SponsorUniversity of Alabama at Birmingham
Academic / other
Locations1 site (Birmingham, Alabama)
StatusRecruiting
StartedSeptember 15, 2025
Main results expectedAugust 31, 2027
Study endsOctober 31, 2027
Registry record updatedJuly 21, 2026
Trial IDNCT07106359 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

  • UAB
    Birmingham, Alabama, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.