NCT04978350

Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lynch Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Educational Workbook	Let's Talk is an educational workbook on Lynch Syndrome and the benefits of cascade screening containing a series of lessons and activities on the following topics: What is Lynch Syndrome? Why should a patient tell a patient's family members about Lynch Syndrome? Create a list of the patient's first-degree relatives at risk for inheriting Lynch Syndrome What should a patient tell family members about Lynch Syndrome? Create a script for the patient to use in discussing Lynch Syndrome with family What are common concerns the patient might hear from family members? How should the patient tell family members about Lynch Syndrome? Create a plan and goals for the patient to reach out to family members What the patient should do if conversation with family is difficult What are common terms and questions about Lynch Syndrome? How can the patient manage having Lynch Syndrome? Where can the patient find additional information about living with Lynch Syndrome?

Timeline

• Start date: 2021-08-01
• Primary completion: 2024-05-02
• Completion: 2024-05-02
• First posted: 2021-07-27
• Last updated: 2025-07-03
• Results posted: 2025-07-03

Locations

1 site across 1 country: United States