Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus
|ClinicalTrials.gov Identifier: NCT00003321|
Recruitment Status : Completed
First Posted : March 22, 2004
Last Update Posted : June 12, 2013
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.
|Condition or disease||Intervention/treatment|
|Esophageal Cancer||Procedure: psychosocial assessment and care Procedure: quality-of-life assessment|
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.
|Study Type :||Observational|
|Estimated Enrollment :||370 participants|
|Official Title:||An International Field Study of the Reliability and Validity of the EORTC-QLQ-C30 and a Disease Specific Questionnaire Module (the EORTC OES-24) in Assessing the Quality of Life of Patients With Oesophageal Cancer|
|Study Start Date :||February 1998|
|Primary Completion Date :||August 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003321
|Australia, Western Australia|
|Sir Charles Gairdner Hospital, Perth|
|Perth, Western Australia, Australia, 6009|
|Clinique Armoricaine De Radiologie|
|Saint Brieux, France, F-22015|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Robert Roessle Klinik|
|Berlin, Germany, D-13122|
|University of Marburg|
|Marburg, Germany, D-35033|
|Diakonissehjemm Ets University Hospital|
|Bergen, Norway, N-5009|
|Hospital De Navarra|
|Pamplona, Spain, 31080|
|Sahlgrenska University Hospital|
|Gothenburg (Goteborg), Sweden, S-413 45|
|Hopital Cantonal Universitaire de Geneva|
|Geneva, Switzerland, CH-1211|
|Bristol Royal Infirmary|
|Bristol, England, United Kingdom, BS2 8HW|
|Study Chair:||Jane Blazeby, MB, CHB, FRCS, BSc, MD||University Hospitals Bristol NHS Foundation Trust|