Clinical trial NCT04978350: Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study
Official title: Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lynch Syndrome
Keywords: Implementation Science
Cascade Screening
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: University of North Carolina, Chapel Hill
name: North Carolina Translational and Clinical Sciences Institute
First posted: 2021-07-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is single arm, interventional study of 15 patients diagnosed with Lynch Syndrome and 4 genetic counselors who are working with the 15 patients.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Patients must have been diagnosed with Lynch Syndrome within the last 365 days.
* Patients and genetic counselors must be age 18 or older.
* Patients must be receiving care from genetic counselors at Ohio State University Comprehensive Cancer Center or at UNC Health System.
* Genetic counselors must provide Lynch Syndrome counseling for patient participants at Ohio State University Comprehensive Cancer Center or at UNC Health System.
* Patients and genetic counselors must be able to speak and read in English.
* Patients and genetic counselors must review informed consent documents and provide verbal consent to participate in the study.

Exclusion Criteria: There are no exclusion criteria for study participants.

Primary outcomes:
measure: Patient Acceptability of Workbook Assessed through Likert Score Scale
timeFrame: Post 4 Weeks of Workbook Use
measure: Genetic Counselor Acceptability of Workbook Assessed through Likert Score Scale
timeFrame: Immediately after using the workbook with enrolled patients
measure: Practicality
timeFrame: Immediately after using the workbook with enrolled patients (for genetic counselors) or Post 4 Weeks of Workbook Use (for patients)
measure: Reach of Information About Lynch Syndrome in Family
timeFrame: Post 4 Weeks of Workbook Use
measure: Reach of Genetic Testing Among Family Members
timeFrame: Post 4 Weeks of Workbook Use
Secondary outcomes:
measure: Knowledge of Lynch Syndrome Assessed through Multiple-Choice Questions
timeFrame: Post 4 Weeks of Workbook Use
measure: Perceived Knowledge of Lynch Syndrome Assessed through Confidence Ratings
timeFrame: Post 4 Weeks of Workbook Use
measure: Patient Self-Efficacy in Communicating about Lynch Syndrome Assessed through Confidence Rating
timeFrame: Post 4 Weeks of Workbook Use
measure: Genetic Counselor Self-Efficacy in Facilitating Family Testing for Lynch Syndrome Assessed through Confidence Rating
timeFrame: Immediately after using the workbook with enrolled patients
measure: Economic Cost of Using Workbook Incurred by Patients
timeFrame: Post 4 Weeks of Workbook Use
measure: Demand for the Workbook by Other Patients or Health Professionals
timeFrame: Immediately after using the workbook with enrolled patients (for genetic counselors) or Post 4 Weeks of Workbook Use (for patients)
measure: Integration of Workbook into Genetic Counselor Work Environment
timeFrame: Immediately after using the workbook with enrolled patients
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: UNC Eshelman School of Pharmacy
name: Megan Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References: