Experiences and Perceptions of Colonoscopy and New Technologies

NCT04747665 | Unknown

• 1 other identifier: IRAS 281674
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Cancer; Colonoscopy

Keywords

Endoscopy; Colonoscopy; Robotic colonoscopy; Artificial intelligence; Patient reported experience

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (8)

• 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

Study Arms (2)

Patients

Patients who have undergone or refused to undergo colonoscopy

Other: Patient and endoscopist reported experience

Endoscopists

Endoscopists who perform or are training to perform colonoscopy

Other: Patient and endoscopist reported experience

Interventions

Patient and endoscopist reported experience OTHER

Exploration of patient and endoscopists experiences of colonoscopy.

Endoscopists; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• One of:
• undergone a colonoscopy
• offered a colonoscopy but declined
• perform or training to perform colonoscopy

You may not qualify if:

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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead
• Cancer Research UK: collaborator

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Intestinal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases

Central Study Contacts

Conchubhair Winters, MBChB

CONTACT

07841043502; conchubhair.winters@nhs.net

Venkat Subramanian

CONTACT

V.Subramanian@leeds.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 10, 2021
• Study Start: February 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

GB (1)