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

NCT07106359 | Enrolling By Invitation

• 2 other identifiers: IRB-300014784R00CA277584
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cascade Testing; Lynch Syndrome; Decision Making; Colorectal Cancer; Uterine Cancer; Cancer Prevention

Outcome Measures

Primary Outcomes (3)

• 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.

  (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.

  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.

  6-months post-randomization

Secondary Outcomes (1)

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

  1-month post-randomization

Other Outcomes (1)

• Psychosocial outcomes

  baseline, 1-month post-randomization, 6-month post-randomization

Study Arms (2)

Information Letter

ACTIVE COMPARATOR

This arm provides an information letter about Lynch syndrome and genetic services.

Behavioral: Information Letter

Information Letter and Booklet

EXPERIMENTAL

This arm provides an information letter with a booklet about Lynch syndrome and genetic services.

Behavioral: Information Letter and Booklet

Interventions

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 and Booklet

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.

Information Letter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UAB

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis; Colorectal Neoplasms; Uterine Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Rectal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)