Initial Testing of a Behavioral Intervention About Genetic Services for Families at Risk of Lynch… (NCT07106359) | Clinical Trial Compass
By InvitationNot Applicable
Initial Testing of a Behavioral Intervention About Genetic Services for Families at Risk of Lynch Syndrome
United States185 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility (recruitment and retention rates, completeness of assessment data)
Timeframe: (recruitment) baseline, 1-month and 6-months post-randomization
2
Use and attitudes towards the education materials
Timeframe: 1-month post-randomization (may also include in 6-month post-randomization
3
Scheduling and attendance of pre-test genetic counseling and/or genetic testing