Colonoscopy Check-up in People With Lynch Syndrome

Prevalence, Determinants, and Challenges of Adherence With Colonoscopy Check-up in People With Lynch Syndrome: a Questionnaire-based Study

Lynch Syndrome, an inherited condition, increases bowel cancer risk. People with Lynch Syndrome are recommended to have regular colonoscopies where a camera in a tube is used to look inside the bowel for cancer and for polyps (growths that sometimes can become cancerous). UK guidelines recommend that people with Lynch Syndrome have colonoscopy check-up every 2 years after reaching a certain age; however, they face many challenges which make it difficult to have the recommended check-up.

Among a subset of people with Lynch Syndrome in England, this study will investigate the:

• percentage who are having colonoscopy check-up as recommended by UK guidelines
• factors influencing whether a person is more/less likely to have the recommended colonoscopy check-up
• views, experiences, and challenges of living with Lynch Syndrome and colonoscopy check-up

This study will collect information from people in the 'Lynch Syndrome registry pilot' using a questionnaire. The Cancer Screening and Prevention Research Group (CSPRG) at Imperial College London are conducting the Lynch Syndrome registry pilot, which is recruiting people with Lynch Syndrome who are aged >18 years and in the Cancer Prevention Programme 3 (CaPP3) trial, from Nov 2022-Nov 2023.

This study will include people in the Lynch Syndrome registry pilot who provided consent on the registry pilot consent form to be contacted about future research and are aged ≥25 years. People who have had previous surgery to remove their rectum will be excluded.

The investigators will use the 'Views, experiences, and challenges of colonoscopy check-up' questionnaire, together with a few pieces of additional information previously collected as part of the Lynch Syndrome registry pilot.

Participation involves completing the questionnaire only. The study will take approximately one year from administering the questionnaire to sharing results with participants.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lynch Syndrome

• Study Type: Observational
• Enrollment (Estimated): 170

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W2 1NY
    • Cancer Screening and Prevention Research Group (CSPRG), Department of Surgery and Cancer, Queen Elizabeth The Queen Mother (QEQM) Building, St Mary's Hospital, Imperial College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include people who are in the Lynch Syndrome registry pilot and meet the eligibility criteria for the present study. The Lynch Syndrome registry pilot is recruiting people with Lynch Syndrome who are aged >18 years and in the CaPP3 trial.

Description

Inclusion Criteria:

• People in the Lynch Syndrome registry pilot who have provided consent to be contacted about future research and are aged ≥25 years

Exclusion Criteria:

• People who have had surgery involving removal of their rectum

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant non-adherence to 2-yearly colonoscopy check-up.	Participant non-adherence to 2-yearly colonoscopy check-up will be assessed on a single occasion, considering participants' three most recent colonoscopy check-ups, measured as a percentage.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The four most important challenges to having colonoscopy check-up for participants.	The four most important challenges to having colonoscopy check-up will be assessed on a single occasion, considering participants' responses in the questionnaire. The questionnaire asks participants to select their most important challenges from a given list, and the top four selections will be considered the most important challenges.	1 day

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Amanda J Cross, PhD, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Estimated): April 3, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Colonoscopy; Surveillance; Lynch Syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Neoplasms; Neoplasms by Site; Disease; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genetic Diseases, Inborn; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Neoplastic Syndromes, Hereditary; DNA Repair-Deficiency Disorders; Syndrome; Colorectal Neoplasms, Hereditary Nonpolyposis
• Other Study ID Numbers: IRAS 329468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No