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

Not Applicable

Not yet recruiting

• Conditions: Cascade Testing; Lynch Syndrome; Decision Making

• Registration Number: NCT07106359
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The randomized controlled pilot trial aims to evaluate and optimize feasibility of the trial methods and intervention and to explore the intervention's preliminary efficacy. Untested relatives of patients with Lynch syndrome will be recruited to complete a baseline survey and will be randomized to receive either the intervention or enhanced usual care information. 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.

Detailed Description

I will conduct a 2-arm randomized controlled pilot trial. I will recruit 48 relatives at risk of LS and randomize them to the behavioral intervention arm or the enhanced usual care arm (with a control pamphlet). Permuted block randomization will generate random blocks of size 4-8 in REDCap. I will only enroll one relative per family, so there is no need to account for "family" as a variable. The primary aim of this pilot trial is to evaluate and optimize feasibility of the trial methods and the behavioral intervention to prepare for a fully powered randomized controlled trial. I will also explore the intervention's preliminary efficacy. I will record the numbers of recruitment and retention and assess completeness of data. Data will be collected at baseline (pre-randomization; demographics/medical history, psychosocial outcome measures), post-intervention (1-month post-randomization; behavioral and psychosocial outcome measures; use of the control pamphlet and behavioral intervention), and follow-up (6-months post-randomization; behavioral and psychosocial outcome measures) using REDCap. A brief exit interview will be conducted at 6-months post-randomization for participants who complete the study to gather any feedback they have. Reasons of those who refuse to participate or drop out of the study will be assessed throughout the study.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-30
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Study Start: 2025-09-01
• Primary Completion: 2027-06-01
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment and retention rates	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.
Completeness of assessment data	baseline, 1-month and 6-months post-randomization	calculate the percentage of complete data for those participants who complete each assessment period.
use of the intervention/EUC materials	1-month post-randomization	assess whether participants read the control pamphlet and the intervention (and complete any exercises in the intervention if applicable) and calculate the proportion of participants who answered "Yes."
attitudes towards the intervention/EUC materials	1-month post-randomization	This is assessed by 4-point Likert-type items (e.g., relevancy of information, tone of message, likelihood of sharing with family; very satisfied/likely to very dissatisfied/unlikely). Frequencies of responses (n (%)) and average scores (mean (SD)) will be calculated for each item.
scheduling and attendance of pre-test genetic counseling and/or genetic testing	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 and reason for no uptake.

Secondary Outcome Measures

Name	Time	Method
scheduling and attendance of pre-test genetic counseling and/or genetic testing	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 and reason for no uptake.

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States