Lynch Syndrome
Conditions
Keywords
Implementation Science, Cascade Screening
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.
Interventions
BEHAVIORALEducational 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?
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of North Carolina, Chapel Hill
North Carolina Translational and Clinical Sciences Institute
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
No masking
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Workbook Assessed Through Likert Score Scale | Post 4 Weeks of Workbook Use | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 08/01/2021 through 04/02/2024 at one cancer center in North Carolina.
Pre-assignment details
A total of 20 subjects consented and started to the study.
Participants by arm
| Arm | Count |
|---|---|
| Educational Workbook Arm Participants will receive an electronic PDF version of an educational workbook via email on cascade screening in families with Lynch Syndrome. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
Baseline characteristics
| Characteristic | Educational Workbook Arm |
|---|---|
| Age, Customized 18-40 years old | 5 Participants |
| Age, Customized <18 years old | 0 Participants |
| Age, Customized 41- 64 years old | 10 Participants |
| Age, Customized Unknown | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 20 participants |
| Sex/Gender, Customized Female | 14 Participants |
| Sex/Gender, Customized Male | 1 Participants |
| Sex/Gender, Customized Unknown/Not reported | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: Post 4 Weeks of Workbook Use
Population: Participants who joined the study and responded to the questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Educational Workbook Arm | Acceptability of Workbook Assessed Through Likert Score Scale | score is higher the threshold | 10 Participants |
| Educational Workbook Arm | Acceptability of Workbook Assessed Through Likert Score Scale | score is below the threshold | 3 Participants |