Experiences and Perceptions of Colonoscopy and New Technologies
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Leeds Teaching Hospitals NHS Trust | Leeds | Yorkshire | United Kingdom | LS9 7TF |
Sponsors and Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Cancer Research UK
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRAS 281674