Assessing Quality of Life of Patients With Stomach Cancer
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||An International Field Study Of The Reliability And Validity Of The EORTC QLQ-C30 And A Disease-Specific Questionnaire Module (The QLQ-STO22) In Assessing The Quality Of Life Of Patients With Gastric Cancer|
- psychometric validity of the STO22 module [ Time Frame: The EORTC QLQ-C30 and the gastric cancer module (QLQ-STO22) will be prospectively administered once before and once after primary treatment. ] [ Designated as safety issue: No ]
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.
- debriefing questionnaire information [ Time Frame: at baseline ] [ Designated as safety issue: No ]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.
- compliance [ Time Frame: at the same timepoints when the QoL questionnaires are completed ] [ Designated as safety issue: No ]Proportion of completed versus expected QoL questionnaires
- correlation between QLQ-C30 and STO22 scores [ Time Frame: before and after treatment ] [ Designated as safety issue: No ]correlations between the different established scales of the QLQ-C30 and the hypothesized STO22 scales will be calculated.
|Study Start Date:||April 2001|
|Study Completion Date:||January 2004|
|Primary Completion Date:||May 2003 (Final data collection date for primary outcome measure)|
No protocol specific interventions. Both palliative or curative treatment allowed.
Other: quality-of-life assessment
QLQ-C30 questionnaire administered. STO22 questionnaire administered.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020826
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Berlin, Germany, D-10117|
|University of Marburg|
|Marburg, Germany, D-35033|
|Hospital De Navarra|
|Pamplona, Spain, 31080|
|Sahlgrenska University Hospital|
|Gothenburg (Goteborg), Sweden, S-413 45|
|Bristol Haematology and Oncology Centre|
|Bristol, England, United Kingdom, BS2 8ED|
|Glasgow, Scotland, United Kingdom, G4 0SF|
|Study Chair:||Jane Blazeby, MB, CHB, FRCS, BSc, MD||University Hospitals Bristol NHS Trust|
|Study Chair:||Thierry Conroy, MD||Centre Alexis Vautrin|