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

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Brief Title

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

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 Type


Primary Outcome

Patient Acceptability of Workbook Assessed through Likert Score Scale

Secondary Outcome

 Knowledge of Lynch Syndrome Assessed through Multiple-Choice Questions


Lynch Syndrome


Educational Workbook

Study Arms / Comparison Groups

 Educational Workbook Arm
Description:  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.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

October 1, 2021

Completion Date

August 2022

Primary Completion Date

August 2022

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.




18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Megan Roberts, PhD, (919) 843-4071, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID

LCCC 20-3115

Secondary IDs


Responsible Party


Study Sponsor

UNC Lineberger Comprehensive Cancer Center


 National Center for Advancing Translational Science (NCATS)

Study Sponsor

Megan Roberts, PhD, Principal Investigator, UNC Eshelman School of Pharmacy

Verification Date

July 2021