Clinical trial · Interventional
Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study
NCT04978350CI-TRIAL-00091766completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational Workbook | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Behavioral: Educational Workbook
Primary outcomes (1)
- measure
- Acceptability of Workbook Assessed Through Likert Score Scale
- timeFrame
- Post 4 Weeks of Workbook Use
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.