Bowel CancerNCT04747665
Experiences and Perceptions of Colonoscopy and New Technologies
An observational study of Bowel Cancer and Colonoscopy, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Cancer, Colonoscopy
- What is being tested?
- Patient and endoscopist reported experience
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- One of:
- undergone a colonoscopy
- offered a colonoscopy but declined
- perform or training to perform colonoscopy
Who cannot join
- Non-English speaking
- Unable to comply with any study requirements
- New or ongoing diagnosis of bowel cancer
Trial locations and contacts
1 site in 1 country.
Venkat Subramanian contact
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, Yorkshire, LS9 7TF
Conchubhair Winters, 07841043502, conchubhair.winters@nhs.net
Venkat Subramanian, V.Subramanian@leeds.ac.uk
About this study
Official title: 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.
- Conditions
- Bowel Cancer, Colonoscopy
- Being tested
- Patient and endoscopist reported experience
- Keywords
- Endoscopy, Colonoscopy, Robotic colonoscopy, Artificial intelligence, Patient reported experience
- Medical subject headings
- Intestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient and endoscopist reported experienceOther
Exploration of patient and endoscopists experiences of colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who have undergone or refused to undergo colonoscopy Receives: Other: Patient and endoscopist reported experience | |
| Endoscopists | Endoscopists who perform or are training to perform colonoscopy Receives: Other: Patient and endoscopist reported experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient participant reported experience of colonoscopy - focus group
Descriptive reporting on thematic analysis of a focus group involving patients exploring their experience of colonoscopy.
Measured: 1 year
Patient participant reported experience of colonoscopy - interviews
Descriptive reporting on thematic analysis following interviews of patients exploring their experience of colonoscopy.
Measured: 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.
Measured: 1 year
Patient participant reported barriers to colonoscopy - interviews
Descriptive reporting on thematic analysis following interviews of patients exploring the barriers to colonoscopy.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Feb 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747665
- Sponsor's protocol ID
- IRAS 281674
- Status last verified
- Feb 2021
- First submitted
- 27 Jan 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If possible to suitably anonymise, exerts from the focus group and interview transcripts will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Endoscopists' Experiences and Perceptions of Colonoscopy and New Technologies in Colonoscopy
- ClinicalTrials.gov ID
- NCT04747665
- Acronym / sponsor ID
- IRAS 281674
- Conditions
- Bowel Cancer, Colonoscopy
- Keywords
- Endoscopy, Colonoscopy, Robotic colonoscopy, Artificial intelligence, Patient reported experience
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Patient and endoscopist reported experiencePatients who have undergone or refused to undergo colonoscopy |
| Endoscopists | – | Other: Patient and endoscopist reported experienceEndoscopists who perform or are training to perform colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- undergone a colonoscopy
- offered a colonoscopy but declined
- perform or training to perform colonoscopy
Key exclusion criteria (3 listed)
- Non-English speaking
- Unable to comply with any study requirements
- New or ongoing diagnosis of bowel cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient and endoscopist reported experienceExploration of patient and endoscopists experiences of colonoscopy. | Other | Endoscopists, Patients |
Primary outcome
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.
8 secondary outcomes
Patient participants thoughts and feelings about robotic colonoscopy - focus group
Time frame: 1 year
Patient participants thoughts and feelings about robotic colonoscopy - interview
Time frame: 1 year
Patient participants thoughts and feelings about artificial intelligence - focus group
Time frame: 1 year
Patient participants thoughts and feelings about artificial intelligence - interviews
Time frame: 1 year
Colonoscopist participants thoughts and feelings about robotic colonoscopy - focus group
Time frame: 1 year
Colonoscopist participants thoughts and feelings about robotic colonoscopy - interviews
Time frame: 1 year
Colonoscopist participants thoughts and feelings about artificial intelligence - focus groups
Time frame: 1 year
Colonoscopist participants thoughts and feelings about artificial intelligence - interviews
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: Undecided. If possible to suitably anonymise, exerts from the focus group and interview transcripts will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venkat Subramanian contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Cancer and Colonoscopy, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Conchubhair Winters, MBChB (07841043502, conchubhair.winters@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient participant reported experience of colonoscopy - focus group (time frame: 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.