Assessing Quality of Life of Patients With Stomach Cancer

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT00020826
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2001-04
• Study First Submitted: 2001-07-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-05
• Study Completion: 2004-01
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-24
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
psychometric validity of the STO22 module	The EORTC QLQ-C30 and the gastric cancer module (QLQ-STO22) will be prospectively administered once before and once after primary treatment.	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.

Secondary Outcome Measures

Name	Time	Method
debriefing questionnaire information	at baseline	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.

Trial Locations

Locations (7)

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre-les-Nancy, France

Universitaetsklinikum Charite; 🇩🇪 Berlin, Germany

University of Marburg; 🇩🇪 Marburg, Germany

Hospital De Navarra; 🇪🇸 Pamplona, Spain

Sahlgrenska University Hospital; 🇸🇪 Gothenburg (Goteborg), Sweden

Bristol Haematology and Oncology Centre; 🇬🇧 Bristol, England, United Kingdom

Royal Infirmary; 🇬🇧 Glasgow, Scotland, United Kingdom