An interventional study of Information Letter and Booklet and Information Letter in Cascade Testing, Lynch Syndrome and Decision Making, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Diagnostic
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.
Lynch syndrome runs in families. It increases the risk of many types of cancer. Pre-test genetic counseling is an opportunity for at-risk people to determine whether genetic testing is right for them. Genetic testing looks for harmful changes in the genes known to cause Lynch syndrome. However, Lynch syndrome is underdiagnosed and uptake of genetic counseling and testing is low, missing opportunities for cancer prevention and early treatment.
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.
139 studies on the registry are indexed under Colorectal Neoplasms, Hereditary Nonpolyposis; 58 are open to participants now.
This study's planned enrollment of 185 is close to the median of 186 across 76 interventional studies indexed under Colorectal Neoplasms, Hereditary Nonpolyposis.
Browse Colorectal Neoplasms, Hereditary Nonpolyposis studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Probands Inclusion Criteria:
Clinical Trial Participants Inclusion Criteria:
This arm provides an information letter about Lynch syndrome and genetic services.
Behavioral: Information Letter
This arm provides an information letter with a booklet about Lynch syndrome and genetic services.
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.
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.
Feasibility (recruitment and retention rates, completeness of assessment data)
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.
Time frame: (recruitment) baseline, 1-month and 6-months post-randomization
Use and attitudes towards the education materials
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.
Time frame: 1-month post-randomization (may also include in 6-month post-randomization
Scheduling and attendance of pre-test genetic counseling and/or genetic testing
Record whether participants scheduled or attended pre-test genetic counseling and genetic testing to calculate the proportion of genetic services uptake.
Time frame: 6-months post-randomization
Scheduling and attendance of pre-test genetic counseling and/or genetic testing
Record whether participants scheduled or attended pre-test genetic counseling and genetic testing to calculate the proportion of genetic services uptake.
Time frame: 1-month post-randomization
Psychosocial outcomes
perceived risk, stress, fear, and coping of LS, cancer worry, colonoscopy experience, family communication, decision conflict, factors influencing decisions, self-efficacy, information received, experience and perception of facilitators and barriers of seeking genetic services for LS, perceived stress, knowledge about LS and genetic services
Time frame: baseline, 1-month post-randomization, 6-month post-randomization
Plan to share: No
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Colorectal Neoplasms, Hereditary Nonpolyposis→
University of Alabama at Birmingham