Experiences and Perceptions of Colonoscopy and New Technologies

February 9, 2021 updated by: The Leeds Teaching Hospitals NHS Trust

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient participants thoughts and feelings about robotic colonoscopy - focus group
Time Frame: 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.
1 year
Patient participants thoughts and feelings about robotic colonoscopy - interview
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 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.
1 year
Colonoscopist participants thoughts and feelings about robotic colonoscopy - interviews
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
Descriptive reporting following thematic analysis of interviews exploring colonoscopists' thoughts and feeling on a artificial intelligence in endoscopy.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Leeds Teaching Hospitals NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cancer Research UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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