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Educational Workbook for Lynch Syndrome
N/A
Recruiting
Led By Megan Roberts, PhD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients and genetic counselors must be age 18 or older.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post 4 weeks of workbook use
Awards & highlights
No Placebo-Only Group
Summary
This trialwill assess if an educational workbook can help improve Lynch Syndrome cascade screening uptake. 15 patients and 5 genetic counselors will take part.
Who is the study for?
This trial is for patients recently diagnosed with Lynch Syndrome at Ohio State University Comprehensive Cancer Center or UNC Health System, and their genetic counselors. Participants must be adults who can speak and read English, have been diagnosed within the last year, and are willing to give verbal consent.
What is being tested?
The study is testing an educational workbook designed to help individuals with Lynch Syndrome and their relatives communicate better about the condition. It's a small pilot study involving 15 patients and 5 genetic counselors to see if this approach is practical.
What are the potential side effects?
Since this trial involves an educational intervention rather than a medical treatment, there are no direct physical side effects expected from participating in this study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after using the workbook with enrolled patients
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after using the workbook with enrolled patients
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Genetic Counselor Acceptability of Workbook Assessed through Likert Score Scale
Patient Acceptability of Workbook Assessed through Likert Score Scale
Practicality
+2 moreSecondary study objectives
Demand for the Workbook by Other Patients or Health Professionals
Economic Cost of Using Workbook Incurred by Patients
Genetic Counselor Self-Efficacy in Facilitating Family Testing for Lynch Syndrome Assessed through Confidence Rating
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Educational Workbook ArmExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
National Center for Advancing Translational Science (NCATS)NIH
99 Previous Clinical Trials
36,149 Total Patients Enrolled
North Carolina Translational and Clinical Sciences InstituteOTHER
59 Previous Clinical Trials
4,439 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,557 Previous Clinical Trials
4,299,033 Total Patients Enrolled
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