An observational study in Oesophageal Cancer, Surgery and Survivorship, sponsored by Karolinska Institutet. Active, not recruiting. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Karolinska Institutet · Observational
The overall objective of this nationwide Swedish project is to identify strategies that can help reduce the suffering and improve the survivorship among patients surgically treated for oesophageal cancer. This objective can be accomplished by a broad research approach that aims to:
This is a Swedish nationwide, prospective, and population-based cohort including 90% of all patients operated on for esophageal or gastroesophageal junctional cancer in Sweden between 1st April 2001 and 31st December 2005. Detailed clinical data were continuously collected from medical records based on a predefined study protocol to ensure uniformity. The clinical data collected included patient and tumor characteristics, treatment details, and follow-up on complications. Patients were followed up with health-related quality of life (HRQL) questionnaires. The core questionnaire (EORTC QLQ-C30) was used to measure aspects of HRQL and symptoms that are applicable for cancer patient in general, whereas the esophageal cancer-specific module (EORTC QLQ-OES18) measured symptoms common among esophageal cancer patients. HRQL was assessed 6 months, 3, 5, 10 and 15 years after surgery while the 20-year follow-up is ongoing. All questionnaires were self-administered, delivered by mail and up to three reminders were sent if required. Collection of HRQL data was obtained anonymously (patients sent their answers to a central administration and not to the treating department). The all-cause and disease-specific mortality was assessed by linkage to the Causes of Death Registry. Informed consent was obtained from each participant.
Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study included patients having been curatively treated, including surgical resection (esophagectomy), for esophageal or gastroesophageal junctional cancer (adenocarcinoma or squamous cell carcinoma) between April 2, 2001 and December 31, 2005.
Exclusion Criteria:
General health-related quality of life (HRQL)
The questionnaire used to measure general HRQL was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This 30-item cancer-specific questionnaire includes one global quality of life scale, five functional scales (physical, role, emotional, cognitive, and social function), three symptom scales (fatigue, nausea, and pain), and six single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire scores were transformed into 0-100 scales. Higher scores in the global quality of life scale, functional scales, and HRQL summary score represent better HRQL or function, while higher scores in the symptom scales or items correspond to more symptoms. Missing data were handled according to the EORTC scoring manual.
Time frame: 6 months, 3, 5, 10,15 and 20 years
Disease specific health-related quality of life (HRQL)
The questionnaire used to measure general HRQL was the European Organisation for Research and Treatment of Cancer Quality of Life Oesophageal Cancer Module 18 questionnaire (EORTC QLQ-OES18). This is an 18-item well-validated questionnaire measuring esophageal cancer-specific symptoms. It comprises four multi-item scales (dysphagia, eating difficulties, reflux, and pain) and six single items (trouble swallowing saliva, choking when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking). The response alternatives make up a four-point Likert scale: \[1\] 'Not at all', \[2\] 'A little', \[3\] 'Quite a bit' and \[4\] 'Very much'. The responses were transformed into a score within the range of 0-100. High scores in scales and single items represent high level of symptoms. Missing data were handled according to the EORTC scoring manual.
Time frame: 6 months, 3, 5, 10,15 and 20 years
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This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet