Experiences and Perceptions of Colonoscopy and New Technologies

• Conditions: Colonoscopy; Bowel Cancer
• Interventions: Other: Patient and endoscopist reported experience

• Registration Number: NCT04747665
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-27
• Status Verified: 2021-02
• Study Start: 2021-02-01
• Study First Submitted QC: 2021-02-09
• Last Update Submitted: 2021-02-09
• Study First Posted: 2021-02-10
• Last Update Posted: 2021-02-10
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

One of:

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopists	Patient and endoscopist reported experience	Endoscopists who perform or are training to perform colonoscopy
Patients	Patient and endoscopist reported experience	Patients who have undergone or refused to undergo colonoscopy

Primary Outcome Measures

Name	Time	Method
Patient participant reported experience of colonoscopy - focus group	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	1 year	Descriptive reporting on thematic analysis following interviews of patients exploring their experience of colonoscopy.
Patient participant reported barriers to colonoscopy - focus group	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	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	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Patient participants thoughts and feelings about robotic colonoscopy - focus group	1 year	Descriptive reporting following thematic analysis of a focus group exploring patients' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope.
Patient participants thoughts and feelings about robotic colonoscopy - interview	1 year	Descriptive reporting following thematic analysis of interviews exploring patients' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope.
Patient participants thoughts and feelings about artificial intelligence - focus group	1 year	Descriptive reporting following thematic analysis of a focus group exploring patients' thoughts and feeling on a artificial intelligence in endoscopy
Patient participants thoughts and feelings about artificial intelligence - interviews	1 year	Descriptive reporting following thematic analysis of interviews exploring patients' thoughts and feeling on a artificial intelligence in endoscopy
Colonoscopist participants thoughts and feelings about robotic colonoscopy - focus group	1 year	Descriptive reporting following thematic analysis of a focus group exploring colonoscopists' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope.
Colonoscopist participants thoughts and feelings about robotic colonoscopy - interviews	1 year	Descriptive reporting following thematic analysis of interviews exploring colonoscopists' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope.
Colonoscopist participants thoughts and feelings about artificial intelligence - focus groups	1 year	Descriptive reporting following thematic analysis of a focus group exploring colonoscopists' thoughts and feeling on a artificial intelligence in endoscopy.
Colonoscopist participants thoughts and feelings about artificial intelligence - interviews	1 year	Descriptive reporting following thematic analysis of interviews exploring colonoscopists' thoughts and feeling on a artificial intelligence in endoscopy.

Trial Locations

Locations (1)

Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, Yorkshire, United Kingdom