NCT07106359 · University of Alabama at Birmingham
Initial Testing of a Behavioral Intervention About Genetic Services for Families at Risk of Lynch Syndrome
What this study is about
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 randomly assigned to receive either the an information letter or an information letter plus a booklet.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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.
Primary outcome measures
Feasibility (recruitment and retention rates, completeness of assessment data)
Time frame: (recruitment) baseline, 1-month and 6-months post-randomization
Record the numbers of probands approached, probands enrolled, probands who provide contact information of at least one potentially eligible relative, relatives approached, enrolled, and completing each phase of the study. Calculate the percentage of complete data for those participants who complete each assessment period.
Use and attitudes towards the education materials
Time frame: 1-month post-randomization (may also include in 6-month post-randomization
Assess the extent to which participants reviewed the information letter and booklet and their attitudes, likelihood of sharing the materials, feedback on the materials and impact on decisions, how the information should be delivered.
Scheduling and attendance of pre-test genetic counseling and/or genetic testing
Time frame: 6-months post-randomization
Record whether participants scheduled or attended pre-test genetic counseling and genetic testing to calculate the proportion of genetic services uptake.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 21, 2026 · Source of record for eligibility and locations