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Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003321
Recruitment Status : Completed
First Posted : March 22, 2004
Last Update Posted : June 12, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Esophageal Cancer Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

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.


Study Design

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Group I: Local or locoregional primary esophageal or esophago-gastric cancer Planned esophagectomy with or without adjuvant or neoadjuvant chemotherapy and/or radiotherapy OR Planned radical radiotherapy with or without chemotherapy Prior endoscopic procedure to relieve dysphagia allowed No distant liver or bone metastasis if undergoing esophagectomy Group II: Metastatic esophageal cancer or local anastomotic recurrence of esophageal cancer or deemed unsuitable for esophagectomy Prior palliation by endoscopic or open intubation, laser treatment, tumor necrosis with alcohol injection or diathermy, or intraluminal radiotherapy allowed Prior palliative radiotherapy or chemotherapy allowed No cerebral metastases

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Group I: At least 3 months Group II: At least 4 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Mentally fit to complete a questionnaire or undergo an interview Aware of diagnosis No concurrent second malignancy except basal cell skin cancer No concurrent participation in other quality-of-life studies

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003321


Locations
Australia, Western Australia
Sir Charles Gairdner Hospital, Perth
Perth, Western Australia, Australia, 6009
France
Clinique Armoricaine De Radiologie
Saint Brieux, France, F-22015
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Germany
Robert Roessle Klinik
Berlin, Germany, D-13122
University of Marburg
Marburg, Germany, D-35033
Norway
Diakonissehjemm Ets University Hospital
Bergen, Norway, N-5009
Spain
Hospital De Navarra
Pamplona, Spain, 31080
Sweden
Sahlgrenska University Hospital
Gothenburg (Goteborg), Sweden, S-413 45
Switzerland
Hopital Cantonal Universitaire de Geneva
Geneva, Switzerland, CH-1211
United Kingdom
Bristol Royal Infirmary
Bristol, England, United Kingdom, BS2 8HW
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Jane Blazeby, MB, CHB, FRCS, BSc, MD University Hospitals Bristol NHS Foundation Trust
More Information

Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003321     History of Changes
Other Study ID Numbers: EORTC-15961-40973
EORTC-15961/40973
First Posted: March 22, 2004    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: June 2013

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
recurrent esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases