Experiences and Perceptions of Colonoscopy and New Technologies

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bowel Cancer; Colonoscopy
• Intervention / Treatment: Other: Patient and endoscopist reported experience

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Conchubhair Winters, MBChB; Phone Number: 07841043502; Email: conchubhair.winters@nhs.net
• Study Contact Backup: Name: Venkat Subramanian; Email: V.Subramanian@leeds.ac.uk

Study Locations

• United Kingdom
  • Yorkshire
    • Leeds, Yorkshire, United Kingdom, LS9 7TF
      • Recruiting
      • Leeds Teaching Hospitals NHS Trust
      • Contact: Venkat Subramanian; Email: V.Subramanian@leeds.ac.uk
      • Contact: Conchubhair Winters; Phone Number: 07841043502; Email: conchubhair.winters@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient invitations will be sent out to those on the emailing list of Crohns and Colitis UK, Bowel Cancer UK, Bowel Research UK and advertised on social media, to target populations likely to have experience in colonoscopy and across a variety of indications. Advertising posters will be placed in the outpatient and endoscopy departments of Leeds Teaching Hospitals NHS Trust.

Endoscopist invitations will be via emailing lists to JAG and ACPGBI members, Gastroenterology trainees and nurse endoscopist groups and advertised on social media, attempting to get a representation of various specialties and roles involved in colonoscopy, such as Gastroenterologists (Consultants and trainees), Surgeons and non-medical endoscopists.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients who have undergone or refused to undergo colonoscopy	Other: Patient and endoscopist reported experience; Exploration of patient and endoscopists experiences of colonoscopy.
Endoscopists; Endoscopists who perform or are training to perform colonoscopy	Other: Patient and endoscopist reported experience; Exploration of patient and endoscopists experiences of colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient participant reported experience of colonoscopy - focus group	Descriptive reporting on thematic analysis of a focus group involving patients exploring their experience of colonoscopy.	1 year
Patient participant reported experience of colonoscopy - interviews	Descriptive reporting on thematic analysis following interviews of patients exploring their experience of colonoscopy.	1 year
Patient participant reported barriers to colonoscopy - focus group	Descriptive reporting on thematic analysis following a focus groups involving patients exploring the barriers to colonoscopy.	1 year
Patient participant reported barriers to colonoscopy - interviews	Descriptive reporting on thematic analysis following interviews of patients exploring the barriers to colonoscopy.	1 year
Colonoscopist participant perceptions of the patient experience of colonoscopy - focus group	Descriptive reporting on thematic analysis of a focus groups involving colonoscopists exploring what they feel to be important patient experience measures in colonoscopy.	1 year
Colonoscopist participant perceptions of the patient experience of colonoscopy - interviews	Descriptive reporting on thematic analysis of interviews of colonoscopists exploring what they feel to be important patient experience measures in colonoscopy.	1 year
Colonoscopist participant perceptions of the patient barriers to colonoscopy - focus group	Descriptive reporting on thematic analysis of a focus group involving colonoscopists exploring what they feel to be important barriers to colonoscopy for patients.	1 year
Colonoscopist participant perceptions of the patient barriers to colonoscopy - interviews	Descriptive reporting on thematic analysis of interviews of colonoscopists exploring what they feel to be important barriers to colonoscopy for patients.	1 year
PREMs patient participant questionnaire	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.	1 year
PREMs colonoscopist participant questionnaire	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.	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust
• Collaborators: Cancer Research UK

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Endoscopy; Colonoscopy; Artificial intelligence; Robotic colonoscopy; Patient reported experience
• Other Study ID Numbers: IRAS 281674

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: If possible to suitably anonymise, exerts from the focus group and interview transcripts will be made available.

Drug and device information, study documents

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