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
- Determine the scale structure, reliability, and validity of the tumor-specific
questionnaire, QLQ-STO22, in assessing the quality of life of patients with gastric
- Determine the questionnaire's sensitivity to change in clinical health status in these
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.
Observational Model: Case-Only, Time Perspective: Prospective
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.
The EORTC QLQ-C30 and the gastric cancer module (QLQ-STO22) will be prospectively administered once before and once after primary treatment.
Jane Blazeby, MB, CHB, FRCS, BSc, MD
University Hospitals Bristol NHS Trust
United States: Federal Government