Skip to main content
Clinical Trials/NCT04747665
NCT04747665
Unknown
Not Applicable

Patient and Endoscopists' Experiences and Perceptions of Colonoscopy and New Technologies in Colonoscopy

The Leeds Teaching Hospitals NHS Trust1 site in 1 country100 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bowel Cancer
Sponsor
The Leeds Teaching Hospitals NHS Trust
Enrollment
100
Locations
1
Primary Endpoint
Patient participant reported experience of colonoscopy - focus group
Last Updated
5 years ago

Overview

Brief Summary

Bowel cancer is the 3rd most common cancer in males and females. Most bowel cancers develop from precancerous polyps in the bowel. Colonoscopy can detect and remove these polyps, thereby reducing the risk of developing bowel cancer. However, colonoscopy is an invasive procedure with inherent risk, and can be both uncomfortable and embarrassing to undergo. The risks and numerous other barriers often mean colonoscopy, and cancer preventing polyp removal, is not performed.

The investigators aim to start the first in-human feasibility clinical investigation of a robotic magnetic colonoscope in 2021. The new device aims to reduce the discomfort and risk associated with colonoscopy. As part of the patient and end user involvement aspect of the project the investigators aim to perform a mixed methodology inductive type research project exploring experiences of colonoscopy for patient and endoscopists.

The study will follow an exploratory mixed methodology format with two parallel work-streams for patients and endoscopists. Each work-stream will consisting of a focus groups (1-2 for each patients and endoscopists), followed by 20 endoscopist and 30 patient in-depth interviews, then an online questionnaire. Each stage will be thematically analysed to form the semi-structured questions for the next stage. The target population will be endoscopists who perform colonoscopy and people who have undergone, or refused to undergo, a colonoscopy. Focus groups will be performed in groups of 6-10 participants, and both interview and focus groups will be performed via video/teleconferencing.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The Leeds Teaching Hospitals NHS Trust
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • undergone a colonoscopy
  • offered a colonoscopy but declined
  • perform or training to perform colonoscopy

Exclusion Criteria

  • Non-English speaking
  • Unable to comply with any study requirements
  • New or ongoing diagnosis of bowel cancer

Outcomes

Primary Outcomes

Patient participant reported experience of colonoscopy - focus group

Time Frame: 1 year

Descriptive reporting on thematic analysis of a focus group involving patients exploring their experience of colonoscopy.

Patient participant reported experience of colonoscopy - interviews

Time Frame: 1 year

Descriptive reporting on thematic analysis following interviews of patients exploring their experience of colonoscopy.

Patient participant reported barriers to colonoscopy - focus group

Time Frame: 1 year

Descriptive reporting on thematic analysis following a focus groups involving patients exploring the barriers to colonoscopy.

Patient participant reported barriers to colonoscopy - interviews

Time Frame: 1 year

Descriptive reporting on thematic analysis following interviews of patients exploring the barriers to colonoscopy.

Colonoscopist participant perceptions of the patient experience of colonoscopy - focus group

Time Frame: 1 year

Descriptive reporting on thematic analysis of a focus groups involving colonoscopists exploring what they feel to be important patient experience measures in colonoscopy.

Colonoscopist participant perceptions of the patient experience of colonoscopy - interviews

Time Frame: 1 year

Descriptive reporting on thematic analysis of interviews of colonoscopists exploring what they feel to be important patient experience measures in colonoscopy.

Colonoscopist participant perceptions of the patient barriers to colonoscopy - focus group

Time Frame: 1 year

Descriptive reporting on thematic analysis of a focus group involving colonoscopists exploring what they feel to be important barriers to colonoscopy for patients.

Colonoscopist participant perceptions of the patient barriers to colonoscopy - interviews

Time Frame: 1 year

Descriptive reporting on thematic analysis of interviews of colonoscopists exploring what they feel to be important barriers to colonoscopy for patients.

PREMs patient participant questionnaire

Time Frame: 1 year

Level of importance given to the reported patient experience measures and barriers (as developed from the interviews and focus groups), assessed by Likert style questions.

PREMs colonoscopist participant questionnaire

Time Frame: 1 year

Perceived level of importance given to the reported patient experience measures and barriers (as developed from the interviews and focus groups), assessed by Likert style questions.

Secondary Outcomes

  • Patient participants thoughts and feelings about robotic colonoscopy - focus group(1 year)
  • Patient participants thoughts and feelings about robotic colonoscopy - interview(1 year)
  • Patient participants thoughts and feelings about artificial intelligence - focus group(1 year)
  • Patient participants thoughts and feelings about artificial intelligence - interviews(1 year)
  • Colonoscopist participants thoughts and feelings about robotic colonoscopy - focus group(1 year)
  • Colonoscopist participants thoughts and feelings about robotic colonoscopy - interviews(1 year)
  • Colonoscopist participants thoughts and feelings about artificial intelligence - focus groups(1 year)
  • Colonoscopist participants thoughts and feelings about artificial intelligence - interviews(1 year)

Study Sites (1)

Loading locations...

Similar Trials