Lynch SyndromeNCT04978350
Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study
A study testing Educational Workbook in people with Lynch Syndrome, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lynch Syndrome
- What is being tested?
- Educational Workbook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 2 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this 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.
Read the 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
- Being tested
- Educational Workbook
- Keywords
- Implementation Science, Cascade Screening
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational WorkbookBehavioural
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?
| Study group | Role | What they receive |
|---|---|---|
| Educational Workbook Arm | Experimental | 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. Receives: Behavioral: Educational Workbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post 4 Weeks of Workbook Use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Aug 2021
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), University of North Carolina, Chapel Hill, North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Megan Roberts, PhD, Principal investigator, UNC Eshelman School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978350
- Sponsor's protocol ID
- 20-3115
- Other IDs
- 1KL2TR002490-01
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2021
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study
- ClinicalTrials.gov ID
- NCT04978350
- Acronym / sponsor ID
- 20-3115
- Conditions
- Lynch Syndrome
- Keywords
- Implementation Science, Cascade Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), University of North Carolina, Chapel Hill, North Carolina Translational and Clinical Sciences Institute
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Posted 3 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Educational Workbook Arm | Experimental | Behavioral: Educational WorkbookParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational WorkbookLet'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? | Behavioural | Educational Workbook Arm |
Primary outcome
Acceptability of Workbook Assessed Through Likert Score Scale
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers.
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Active, not recruitingObservational study
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RecruitingObservational study
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Active, not recruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Roberts, PhD principal investigator
UNC Eshelman School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Workbook in people with Lynch Syndrome, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Workbook Assessed Through Likert Score Scale (time frame: Post 4 Weeks of Workbook Use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.