Assessing Quality of Life of Patients With Stomach Cancer
- Conditions
- Gastric Cancer
- Interventions
- Other: quality-of-life assessment
- Registration Number
- NCT00020826
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 267
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description gastric adenocarcinoma quality-of-life assessment No protocol specific interventions. Both palliative or curative treatment allowed.
- 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)
Sahlgrenska University Hospital
🇸🇪Gothenburg (Goteborg), Sweden
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
University of Marburg
🇩🇪Marburg, Germany
Universitaetsklinikum Charite
🇩🇪Berlin, Germany
Hospital De Navarra
🇪🇸Pamplona, Spain
Royal Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom