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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

Study 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.Check my eligibility

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.See study design

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 below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after using the workbook with enrolled patients (for genetic counselors) or post 4 weeks of workbook use (for patients)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after using the workbook with enrolled patients (for genetic counselors) or post 4 weeks of workbook use (for patients)

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after using the workbook with enrolled patients (for genetic counselors) or post 4 weeks of workbook use (for patients) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Genetic Counselor Acceptability of Workbook Assessed through Likert Score Scale

Patient Acceptability of Workbook Assessed through Likert Score Scale

Practicality

+2 more

Secondary outcome measures

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 more

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Science (NCATS)NIH

99 Previous Clinical Trials

36,290 Total Patients Enrolled

North Carolina Translational and Clinical Sciences InstituteOTHER

56 Previous Clinical Trials

4,284 Total Patients Enrolled

University of North Carolina, Chapel HillOTHER

1,508 Previous Clinical Trials

4,191,023 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary objective of this clinical trial?

"The primary purpose of this trial is to assess the practicality of a 4-week workbook. As secondary objectives, knowledge about Lynch Syndrome will be tested through multiple choice questions; integration success and challenges with regards to the workbook into genetic counselor workflow environments via qualitative interviews conducted on Zoom; as well as patient self-efficacy in communicating Lynch Syndrome to family members rated by confidence score (1 being very low and 5 indicating high conidence)."

Answered by AI

Is there space available for participants in this investigation?

"The data hosted on clinicaltrials.gov suggests that this medical trial is open to enrolment, with a commencement date of October 1st 2021 and the most recent update being made in late October 2022."

Answered by AI

How many people are included in this trial at its peak?

"Affirmative. According to the data accessible on clinicaltrials.gov, this medical research has been recruiting since October 1st 2021 and its latest update was made on October 24th 2022. The trial is looking for 19 participants across two sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04978350.