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Protocol for LAsting Symptoms after Oesophageal Resectional Surgery (LASORS): multicentre validation cohort study

Protocol for LAsting Symptoms after Oesophageal Resectional Surgery (LASORS): multicentre validation cohort study
Protocol for LAsting Symptoms after Oesophageal Resectional Surgery (LASORS): multicentre validation cohort study

Introduction: surgery is the primary curative treatment for oesophageal cancer, with considerable recent improvements in long-term survival. However, surgery has a long-lasting impact on patient's health-related quality of life (HRQOL). Through a multicentre European study, our research group was able to identify key symptoms that affect patient's HRQOL. These symptoms were combined to produce a tool to identify poor HRQOL following oesophagectomy (LAsting Symptoms after Oesophageal Resection (LASOR) tool). The objective of this multicentre study is to validate a six-symptom clinical tool to identify patients with poor HRQOL for use in everyday clinical practice.

Methods and analysis: included patients will: (1) be aged 18 years or older, (2) have undergone an oesophagectomy for cancer between 2015 and 2019, and (3) be at least 12 months after the completion of adjuvant oncological treatments. Patients will be given the previously created LASOR questionnaire. Each symptom from the LASOR questionnaire will be graded according to impact on quality of life and frequency of the symptom, with a composite score from 0 to 5. The previously developed LASOR symptom tool will be validated against HRQOL as measured by the European Organisation for Research and Treatment of Cancer QLQC30 and OG25.

Sample size: with a predicted prevalence of poor HRQOL of 45%, based on the previously generated LASOR clinical symptom tool, to validate this tool with a sensitivity and specificity of 80%, respectively, a minimum of 640 patients will need to be recruited to the study.

Ethics and dissemination: NHS Health Research Authority (North East-York Research Ethics Committee) approval was gained 8 November 2019 (REC reference 19/NE/0352). Multiple platforms will be used for the dissemination of the research data, including international clinical and patient group presentations and publication of research outputs in a high impact clinical journal.

oesophageal disease, oncology, surgery
2044-6055
e034897
Markar, Sheraz Rehan
c0870699-2183-41ea-a499-be9a90ba78ed
Griffiths, Ewen A
4488f717-0b5f-4203-b0fd-15f084110442
Behrens, Paul
0b0e4a03-0e40-4cb8-bbeb-0373fa1bc9a4
Singh, Pritam
b3816602-3432-4b1a-b332-c62e9fac55a4
Vohra, Ravi S
349f34e8-591b-4c27-8c04-8873caa8f802
Gossage, James
17d9224b-b967-45af-9a09-6a113b53fb69
Underwood, Timothy
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Hanna, George B
1122c9e7-d132-40e1-9ebf-f43ae888d597
LASORS study group
Markar, Sheraz Rehan
c0870699-2183-41ea-a499-be9a90ba78ed
Griffiths, Ewen A
4488f717-0b5f-4203-b0fd-15f084110442
Behrens, Paul
0b0e4a03-0e40-4cb8-bbeb-0373fa1bc9a4
Singh, Pritam
b3816602-3432-4b1a-b332-c62e9fac55a4
Vohra, Ravi S
349f34e8-591b-4c27-8c04-8873caa8f802
Gossage, James
17d9224b-b967-45af-9a09-6a113b53fb69
Underwood, Timothy
8e81bf60-edd2-4b0e-8324-3068c95ea1c6
Hanna, George B
1122c9e7-d132-40e1-9ebf-f43ae888d597

Underwood, Timothy , LASORS study group (2020) Protocol for LAsting Symptoms after Oesophageal Resectional Surgery (LASORS): multicentre validation cohort study. BMJ Open, 10 (6), e034897. (doi:10.1136/bmjopen-2019-034897).

Record type: Article

Abstract

Introduction: surgery is the primary curative treatment for oesophageal cancer, with considerable recent improvements in long-term survival. However, surgery has a long-lasting impact on patient's health-related quality of life (HRQOL). Through a multicentre European study, our research group was able to identify key symptoms that affect patient's HRQOL. These symptoms were combined to produce a tool to identify poor HRQOL following oesophagectomy (LAsting Symptoms after Oesophageal Resection (LASOR) tool). The objective of this multicentre study is to validate a six-symptom clinical tool to identify patients with poor HRQOL for use in everyday clinical practice.

Methods and analysis: included patients will: (1) be aged 18 years or older, (2) have undergone an oesophagectomy for cancer between 2015 and 2019, and (3) be at least 12 months after the completion of adjuvant oncological treatments. Patients will be given the previously created LASOR questionnaire. Each symptom from the LASOR questionnaire will be graded according to impact on quality of life and frequency of the symptom, with a composite score from 0 to 5. The previously developed LASOR symptom tool will be validated against HRQOL as measured by the European Organisation for Research and Treatment of Cancer QLQC30 and OG25.

Sample size: with a predicted prevalence of poor HRQOL of 45%, based on the previously generated LASOR clinical symptom tool, to validate this tool with a sensitivity and specificity of 80%, respectively, a minimum of 640 patients will need to be recruited to the study.

Ethics and dissemination: NHS Health Research Authority (North East-York Research Ethics Committee) approval was gained 8 November 2019 (REC reference 19/NE/0352). Multiple platforms will be used for the dissemination of the research data, including international clinical and patient group presentations and publication of research outputs in a high impact clinical journal.

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Accepted/In Press date: 7 April 2020
Published date: 3 June 2020
Keywords: oesophageal disease, oncology, surgery

Identifiers

Local EPrints ID: 444330
URI: http://eprints.soton.ac.uk/id/eprint/444330
ISSN: 2044-6055
PURE UUID: fc3cce64-c811-4d78-86cd-ef0c6ee2a158
ORCID for Timothy Underwood: ORCID iD orcid.org/0000-0001-9455-2188

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Date deposited: 13 Oct 2020 16:39
Last modified: 06 Jun 2024 01:41

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Contributors

Author: Sheraz Rehan Markar
Author: Ewen A Griffiths
Author: Paul Behrens
Author: Pritam Singh
Author: Ravi S Vohra
Author: James Gossage
Author: George B Hanna
Corporate Author: LASORS study group

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