Abstract
IntroductionSurgery 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 analysisIncluded 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 sizeWith 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 disseminationNHS 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.
Highlights
Surgery is the primary curative treatment for oesophageal cancer, with considerable recent improvements in long-term survival
Through a multicentre European study of 876 patients, we recently identified three key symptoms that were independently associated with poor health-related quality of life (HRQOL) as measured by validated EORTC tools.[14]
We presented these findings to the Oesophageal Patient Association (UK) and Heartburn Cancer UK patient support groups who identified a further three symptoms to be included in the final clinical symptom tool that we aim to validate in this present UK study
Summary
►► Large, multicentre, contemporenous, European study of quality of life after esophagectomy. ►► Quality of Life Questionnaire/LAsting Symptoms after Oesophageal Resection (LASOR) tool has been developed in association with patient with oesophageal cancer support group charities (Heartburn Cancer UK and Oesophageal Patients Association). With the recent improvements in survival, the assessment of patient-reported outcome measures including patient’s health- related quality of life (HRQOL) and the impact of long-term symptoms in survivorship has become increasingly important. Through a multicentre European study of 876 patients, we recently identified three key symptoms that were independently associated with poor HRQOL as measured by validated EORTC tools.[14] We presented these findings to the Oesophageal Patient Association (UK) and Heartburn Cancer UK patient support groups who identified a further three symptoms to be included in the final clinical symptom tool that we aim to validate in this present UK study
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