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

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.

Study Overview

• Status: Completed
• Conditions: Lynch Syndrome
• Intervention / Treatment: Behavioral: Educational Workbook

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina At Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Educational Workbook Arm; Participants in the Educational Workbook Arm will receive an electronic PDF version of an educational workbook via email on cascade screening in families with Lynch Syndrome. Genetic counselors will introduce the workbook to enrolled patients with Lynch Syndrome. Patient participants will use the activities and information in the workbook to communicate about Lynch Syndrome with family members.

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Workbook Assessed Through Likert Score Scale	Participants evaluated the workbook using seven acceptability criteria rated on a 5-point Likert scale, where 1 indicated "Strongly Disagree" and 5 indicated "Strongly Agree." The criteria assessed ease of use, clarity of exercises, enjoyment, usefulness for understanding Lynch Syndrome, support for communicating genetic information, time acceptability, and overall satisfaction. Each participant's responses were summed up to produce a total acceptability score ranging from 7 to 35, with higher scores indicating greater acceptability. A score of 28 or higher (80% of the maximum score, which was 35) was defined as an acceptable intervention.	Post 4 Weeks of Workbook Use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of Lynch Syndrome Assessed through Multiple-Choice Questions	Patients will answer 7 multiple choice questions about Lynch Syndrome and its implications for patients and family members. A score of 4 or more questions correct indicates moderate to high knowledge about Lynch Syndrome. The knowledge scores will be measured through an electronic survey.	Post 4 Weeks of Workbook Use
Perceived Knowledge of Lynch Syndrome Assessed through Confidence Ratings	Patients will rate their confidence in their answer to each of the 7 knowledge questions on a scale of 1 (very low confidence) to 5 (very high confidence). A combined score of 21 or higher suggests moderate to high perceived knowledge. Perceived Knowledge will be measured through an electronic survey.	Post 4 Weeks of Workbook Use
Patient Self-Efficacy in Communicating about Lynch Syndrome Assessed through Confidence Rating	Patients will score themselves on 5 questions about their confidence in communicating Lynch Syndrome to family members. Scores for each question go from 1 (very low confidence) to 5 (very high confidence). A cumulative score of 15 or higher indicates moderate to high self-efficacy related to family communication. Genetic counselor self-efficacy in communicating about Lynch Syndrome will be measured through an electronic survey.	Post 4 Weeks of Workbook Use
Genetic Counselor Self-Efficacy in Facilitating Family Testing for Lynch Syndrome Assessed through Confidence Rating	Genetic counselors will score themselves on 5 questions about their confidence in conducting family testing with Lynch Syndrome patients. Scores for each question go from 1 (very low confidence) to 5 (very high confidence). A cumulative score of 15 or higher indicates moderate to high self-efficacy related to facilitating cascade screening in families. Genetic counselor self-efficacy in facilitating family testing for Lynch Syndrome will be measured through an electronic survey.	Immediately after using the workbook with enrolled patients
Economic Cost of Using Workbook Incurred by Patients	Patients will answer a set of questions about out-of-pocket expenses they incurred while using the workbook along with other resources they needed to complete the workbook. Non-monetary costs will be converted into dollar form. Average cost to the patient will be calculated. We will also estimate average costs across variation in transportation use, number of relatives, employment status and benefits, and incidental costs across participants. Costs will be measured through an electronic survey.	Post 4 Weeks of Workbook Use
Demand for the Workbook by Other Patients or Health Professionals	Patient and genetic counselor's perceptions of the expected demand for the workbook by other patients with Lynch Syndrome or other health professionals involved in Lynch Syndrome care will be discussed in qualitative interviews conducted via Zoom. Major themes about expected demand will be identified and coded for in the interview transcriptions. Major themes will be compiled.	Immediately after using the workbook with enrolled patients (for genetic counselors) or Post 4 Weeks of Workbook Use (for patients)
Integration of Workbook into Genetic Counselor Work Environment	Genetic counselors will answer questions about the workbook integration into their workflows and work environment during qualitative interviews conducted via Zoom. Major themes about integration success and challenges will be identified and coded in the interview transcriptions. Major themes will be compiled.	Immediately after using the workbook with enrolled patients

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: University of North Carolina, Chapel Hill; National Center for Advancing Translational Sciences (NCATS); North Carolina Translational and Clinical Sciences Institute
• Investigators: Principal Investigator: Megan Roberts, PhD, UNC Eshelman School of Pharmacy

Publications and helpful links

Helpful Links

• Clinical trials at UNC Lineberger

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): May 2, 2024
• Study Completion (Actual): May 2, 2024

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Implementation Science; Cascade Screening
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Genetic Diseases, Inborn; Metabolic Diseases; Intestinal Diseases; Disease; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Neoplastic Syndromes, Hereditary; DNA Repair-Deficiency Disorders; Syndrome; Colorectal Neoplasms, Hereditary Nonpolyposis
• Other Study ID Numbers: 20-3115; 1KL2TR002490-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No