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

Conditions

• Cancer Prevention
• Cascade Testing
• Colorectal Cancer
• Decision Making
• Lynch Syndrome
• Uterine Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Information Letter and Booklet — BEHAVIORAL
  an information letter with a booklet for at-risk families highlighting implications of family history, testing considerations, steps for genetic testing, and potential costs.
• Information Letter — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Sep 15, 2025

Status verified

Jan 2026

Primary completion

Jun 30, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

185 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Active Comparator: Information Letter
  This arm provides an information letter about Lynch syndrome and genetic services.
• Experimental: Information Letter and Booklet
  This arm provides an information letter with a booklet about Lynch syndrome and genetic services.

Primary Outcome Measure

Feasibility (recruitment and retention rates, completeness of assessment data) [ Time Frame: (recruitment) baseline, 1-month and 6-months post-randomization ]

Locations (1)

Find similar trials in Birmingham, AL

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