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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00003321

Collaborator

(none)

370

Enrollment

Locations

Patients Per Site

Study Details

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	Phase
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

Anticipated 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 :

Feb 1, 1998

Actual Primary Completion Date :

Aug 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sir Charles Gairdner Hospital, Perth	Perth	Western Australia	Australia	6009
2	Clinique Armoricaine De Radiologie	Saint Brieux		France	F-22015
3	Centre Alexis Vautrin	Vandoeuvre-les-Nancy		France	54511
4	Robert Roessle Klinik	Berlin		Germany	D-13122
5	University of Marburg	Marburg		Germany	D-35033
6	Diakonissehjemm Ets University Hospital	Bergen		Norway	N-5009
7	Hospital De Navarra	Pamplona		Spain	31080
8	Sahlgrenska University Hospital	Gothenburg (Goteborg)		Sweden	S-413 45
9	Hopital Cantonal Universitaire de Geneva	Geneva		Switzerland	CH-1211
10	Bristol Royal Infirmary	Bristol	England	United Kingdom	BS2 8HW