Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus
- Conditions
- Esophageal Cancer
- Registration Number
- NCT00003321
- Brief Summary
RATIONALE: Questionnaires that measure quality of life may improve the ability to plan treatment for patients who have cancer of the esophagus.
PURPOSE: This clinical trial studies quality-of-life assessments of patients with cancer of the esophagus who are receiving treatment.
- Detailed Description
OBJECTIVES: I. Test the psychometric, clinical, and cross cultural validity and reliability of the quality-of-life questionnaire EORTC-QLQ-C30 (version 3.0) in conjunction with the esophageal cancer-specific module EORTC QLQ-OES-24 in patients with esophageal cancer.
OUTLINE: This is a multicenter study. Patients are stratified by treatment (potentially curative vs purely palliative). Patients receiving potentially curative treatment are further stratified according to study treatment (esophagectomy alone vs esophagectomy plus adjuvant or neoadjuvant chemo/radiotherapy vs radical radiotherapy with or without chemotherapy). Patients receiving purely palliative treatment are further stratified according to study treatment (intubation/laser/ethanol injection vs palliative chemo/radiotherapy without endoscopic relief of dysphagia). Patients are administered two questionnaires: (1) The EORTC QLQ-C30 (version 3.0) is a 30-item questionnaire about patient ability to function, symptoms related to the cancer and its treatment, overall health and quality of life, and perceived financial impact of the cancer and its treatment. (2) The EORTC QLQ-OES-24 is a 24-item esophageal cancer-specific questionnaire supplementing EORTC QLQ-C30 with information about disease and treatment-related symptoms and side effects, dysphagia, nutrition, and social and emotional effects of esophageal cancer. Both questionnaires are administered once before and once during or after treatment.
PROJECTED ACCRUAL: 370 patients (170 with locoregional disease, 200 with metastatic disease) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Sir Charles Gairdner Hospital, Perth
🇦🇺Perth, Western Australia, Australia
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieux, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Robert Roessle Klinik
🇩🇪Berlin, Germany
University of Marburg
🇩🇪Marburg, Germany
Diakonissehjemm Ets University Hospital
🇳🇴Bergen, Norway
Hospital De Navarra
🇪🇸Pamplona, Spain
Sahlgrenska University Hospital
🇸🇪Gothenburg (Goteborg), Sweden
Hopital Cantonal Universitaire de Geneva
🇨🇭Geneva, Switzerland
Bristol Royal Infirmary
🇬🇧Bristol, England, United Kingdom
Sir Charles Gairdner Hospital, Perth🇦🇺Perth, Western Australia, Australia