Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-03-16 @ 12:15 PM
Study NCT ID:
NCT04978350
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2021-06-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study
Status:
COMPLETED
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 investigators will evaluate the feasibility of an intervention to improve Lynch syndrome cascade screening uptake. The investigators will conduct a pilot study among 15 patients diagnosed with Lynch Syndrome and 5 genetic counselors to assess the feasibility and intermediate outcomes of an educational workbook containing exercises and resources to improve family communication among individuals with Lynch Syndrome and first-degree relatives of individuals with Lynch Syndrome.
Detailed Description:
Genetic counselors of patients with Lynch Syndrome and patients with Lynch Syndrome will test a planning tool (referred to as an educational workbook) for cascade screening. Five genetic counselors and 15 patients with Lynch Syndrome will be recruited from the UNC Health System and the Ohio State Comprehensive Cancer Center. Genetic counselors will identify patients with Lynch Syndrome and introduce the study opportunity to potential patient participants. All patients and genetic counselors will complete a telephone enrollment call and provide informed consent to participate. Enrolled patients will work with enrolled genetic counselors to complete the first workbook exercise and then patients will complete the remaining exercises alone for over approximately 1 month. After genetic counselors and patients have completed using the workbook, the investigators will conduct qualitative virtual interviews over Zoom and a post-intervention electronic survey to understand the participants' experiences using the workbook. The investigators aim to understand the feasibility of using the workbook as an intervention in clinical practice to improve genetic testing uptake in families with Lynch Syndrome.
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 |
|---|---|---|---|---|
| 1KL2TR002490-01 | NIH | None | https://reporter.nih.gov/quic… | View |