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Clinical Trials/NCT00003321
NCT00003321
Completed
Not Applicable

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

European Organisation for Research and Treatment of Cancer - EORTC10 sites in 8 countries370 target enrollmentFebruary 1998

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Enrollment
370
Locations
10
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1998
End Date
August 2001
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (10)

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