Initial Testing of a Behavioral Intervention About Genetic Services for Families at Risk of Lynch Syndrome
NCT ID: NCT07106359
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
185 participants
INTERVENTIONAL
2025-09-15
2027-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Information Letter
This arm provides an information letter about Lynch syndrome and genetic services.
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.
Information Letter and Booklet
This arm provides an information letter with a booklet about Lynch syndrome and genetic services.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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)
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Haoyang Yan
assistant professor
Locations
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UAB
Birmingham, Alabama, United States
Countries
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Other Identifiers
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IRB-300014784
Identifier Type: -
Identifier Source: org_study_id
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