Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-02 @ 2:09 AM
Study NCT ID:
NCT07106359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Testing of a Behavioral Intervention About Genetic Services for Families at Risk of Lynch Syndrome
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
A Randomized Controlled Pilot Trial of a Behavioral Intervention to Increase Uptake of Genetic Services Among Relatives at Risk of Lynch Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R00CA277584 | NIH | None | https://reporter.nih.gov/quic… | View |