Assessing Quality of Life of Patients With Stomach 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.
  
  

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.