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NCT Number: NCT07106359

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

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.

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Key information

Conditions

Cascade Testing Cancer Prevention Colonic Diseases Colorectal Cancer Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Decision Making Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Intestinal Diseases Intestinal Neoplasms Lynch Syndrome Metabolic Diseases Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases Rectal Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Scheduling and attendance of pre-test genetic counseling and/or genetic testing

    Time frame: 1-month post-randomization

    Record whether participants scheduled or attended pre-test genetic counseling and genetic testing to calculate the proportion of genetic services uptake.

Other outcomes

  1. Psychosocial outcomes

    Time frame: baseline, 1-month post-randomization, 6-month post-randomization

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Haoyang Yan, PhD

CONTACT

[email protected]

205-914-2249

Kaylee Burgan, MS

CONTACT

[email protected]

205-914-2249

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Randomized Controlled Pilot Trial of a Behavioral Intervention to Increase Uptake of Genetic Services Among Relatives at Risk of Lynch Syndrome

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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