Quality of life measures in Barrett's Oesophagus care pathways

Not Applicable

• Conditions: Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology; UKCRC code/ Disease: Oral and Gastrointestinal/ Diseases of oesophagus, stomach and duodenum; Digestive System; Diseases of oesophagus, stomach and duodenum

• Registration Number: ISRCTN76017289
• Lead Sponsor: Wrightington, Wigan And Leigh NHS Foundation Trust

Brief Summary

2017 Results article in https://pubmed.ncbi.nlm.nih.gov/28867477/ results (added 09/11/2020) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30430714/ results (added 09/11/2020) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31205652/ results (added 09/11/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32337055/ results (added 09/11/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-01
• Last Update Posted: 9 January 2023
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

1. Must have capacity to give informed consent
2. >18 years old. No upper age limit.
3. Male or Female
4. Meet the diagnostic criteria for each group
4.1. Non-Dysplastic Barrett’s Oesophagus. All patients enrolled in surveillance who have been given a diagnosis of BO irrespective of current histology (lack of intestinal metaplasia on latest biopsies is not a criterion for exclusion providing future surveillance is indicated/recommended)
4.2. Barrett’s oesophagus with dysplasia or early oesophageal adenocarcinoma. Any patient with BO diagnosed with low grade dysplasia, high grade dysplasia or early OAC eligible for ET.
4.3. Colonic Polyps. Participants currently undergoing endoscopic surveillance for colonic polyps
4.4. Gastro-oesophageal reflux disease. Participants without BO who have been diagnosed with any of the following; gastroesophageal reflux + oesophagitis”, gastroesophageal reflux – oesophagitis”, gastroesophageal reflux disease”, GORD”, acid reflux” or heartburn”, dyspepsia”.
4.5. Normal Healthy Individuals. Population control participants who do not exhibit significant co-morbidities

Exclusion Criteria

1. Lack capacity to consent
2. <18 years old

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Health related quality of life is measured using a self-administered questionnaire as a one off assessment in all groups and at baseline and between 4-12 months in the Barrett’s oesophagus with dysplasia group.<br> 2. Follow up needs and patient burdens are measured using semi-structured in-depth patient interviews<br> 2.1 Health related quality of life is measured using a self-administered questionnaire after intervention (clinic arms), after endoscopy (non-clinic arm) and then 4 and 6 months later (all arms)<br>

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures.