Assessing Quality of Life of Patients With Stomach Cancer

N/ACompletedNCT00020826

European Organisation for Research and Treatment of Cancer - EORTC267 enrolled

Overview

RATIONALE: Assessing quality of life in patients who are undergoing cancer treatment may help determine the effect of treatment on these patients. PURPOSE: Clinical trial to study the effectiveness of a quality of life assessment in patients who are receiving treatment for stomach cancer.

OBJECTIVES: * Determine the scale structure, reliability, and validity of the tumor-specific questionnaire, QLQ-STO22, in assessing the quality of life of patients with gastric cancer. * Determine the questionnaire's sensitivity to change in clinical health status in these patients. OUTLINE: Patients are stratified according to type of treatment (potentially curative vs potentially palliative), disease stage (local and locoregional vs metastatic), Karnofsky performance status (less than 80% vs more than 80%), and initial weight gain (none vs less than 10% of total body weight vs 10% or more of total body weight). * Curatively Treated Group: Quality of life is assessed at 4 weeks prior to surgery and 3 months after surgery in patients receiving total or partial gastrectomy with curative intent; at 4 weeks prior to chemotherapy and/or radiotherapy, 4 weeks prior to surgery, and 3 months after surgery in patients receiving neoadjuvant chemotherapy and/or radiotherapy followed by total or partial gastrectomy with curative intent; at 4 weeks prior to chemotherapy and/or radiotherapy and 6 weeks after completion of therapy in patients receiving adjuvant chemotherapy and/or radiotherapy following total or partial gastrectomy; and at 4 weeks prior to therapy and 3 months after completion of therapy in patients receiving endoscopic mucosal resection or laparoscopic wedge resection. * Palliatively Treated Group: Quality of life is assessed at 3 weeks prior to palliative therapy and 4 weeks after beginning palliative therapy. PROJECTED ACCRUAL: Approximately 220 patients (110 per group) will be accrued for this study within 2 years.

Study Type

OBSERVATIONAL

Enrollment

267

Conditions

Gastric Cancer

Interventions

quality-of-life assessmentOTHER

QLQ-C30 questionnaire administered. STO22 questionnaire administered.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed gastric adenocarcinoma * Patients treated with curative intent according to one of the following criteria: * Plan to undergo total or partial gastrectomy with curative intent * Plan to receive neoadjuvant chemotherapy and/or radiotherapy followed by total or partial gastrectomy with curative intent * Prior total or partial gastrectomy with curative intent and currently receiving adjuvant chemotherapy and/or radiotherapy * Prior endoscopic mucosal resection or laparoscopic wedge resection of early gastric cancer OR * Patients with initial diagnosis of gastric cancer or recurrent disease with plans to receive one of the following therapies with palliative intent: * Total or partial gastrectomy or bypass procedure * Endoscopic procedure (e.g., stent insertion) * Chemotherapy and/or radiotherapy * Supportive measures only * No concurrent enrollment on other quality of life study that would interfere with this study * Not previously enrolled on this study PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Any performance status Life expectancy: * At least 2 months for patients treated with curative intent * At least 4 weeks for patients treated with palliative intent Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other concurrent malignancies except basal cell carcinoma of the skin * No mental impairment that would preclude completion of questionnaire * No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics

Locations (7)

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, France

Universitaetsklinikum Charite

Berlin, Germany

University of Marburg

Marburg, Germany

Hospital De Navarra

Pamplona, Spain

Outcomes

Primary Outcomes

psychometric validity of the STO22 module

Quality of life scores will be evaluated for psychometric validity by: * Scale structure using multi-trait scaling analysis * Reliability using tests of internal consistency * Test-retest reliability in patients recruited in the UK * Validity using inter-scale correlations and known group comparisons * Sensitivity to change using two measurements of Quality of Life and ANOVA to look for the significance of changes in quality of life scores as a function of observed changes in clinical status over time.

Time frame: The EORTC QLQ-C30 and the gastric cancer module (QLQ-STO22) will be prospectively administered once before and once after primary treatment.

Secondary Outcomes

debriefing questionnaire information

Patients will be asked to complete a short debriefing questionnaire covering questions about the time taken to complete the EORTC QLQ-C30 and QLQ-STO22; the need for help in completing the questionnaires and querying whether any of the questionnaire items were confusing; difficult to answer or upsetting.

Time frame: at baseline

Data from ClinicalTrials.gov

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