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临床试验/NCT04747665
NCT04747665Unknown不适用

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

The Leeds Teaching Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Patient participant reported experience of colonoscopy - focus group

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • undergone a colonoscopy
  • offered a colonoscopy but declined
  • perform or training to perform colonoscopy

排除标准

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

结局指标

主要结局

Patient participant reported experience of colonoscopy - focus group

时间窗: 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

时间窗: 1 year

Descriptive reporting on thematic analysis following interviews of patients exploring their experience of colonoscopy.

Patient participant reported barriers to colonoscopy - focus group

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)
  • Colonoscopist participants thoughts and feelings about robotic colonoscopy - interviews(1 year)
  • Colonoscopist participants thoughts and feelings about artificial intelligence - focus groups(1 year)
  • Colonoscopist participants thoughts and feelings about artificial intelligence - interviews(1 year)

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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