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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


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Esophageal Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Jane Blazeby, MB, CHB, FRCS, BSc, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospitals Bristol NHS Trust

Authority:

United States: Federal Government

Study ID:

EORTC-15961-40973

NCT ID:

NCT00003321

Start Date:

February 1998

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • stage I esophageal cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

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