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
18 Years
N/A
Both
Gastric Cancer
Trial Information
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
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed gastric adenocarcinoma
- Patients treated with curative intent according to one of the following criteria:
- Plan to undergo total or partial gastrectomy with curative intent
- Plan to receive neoadjuvant chemotherapy and/or radiotherapy followed by total
or partial gastrectomy with curative intent
- Prior total or partial gastrectomy with curative intent and currently receiving
adjuvant chemotherapy and/or radiotherapy
- Prior endoscopic mucosal resection or laparoscopic wedge resection of early
gastric cancer OR
- Patients with initial diagnosis of gastric cancer or recurrent disease with plans to
receive one of the following therapies with palliative intent:
- Total or partial gastrectomy or bypass procedure
- Endoscopic procedure (e.g., stent insertion)
- Chemotherapy and/or radiotherapy
- Supportive measures only
- No concurrent enrollment on other quality of life study that would interfere with
this study
- Not previously enrolled on this study
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- Any performance status
Life expectancy:
- At least 2 months for patients treated with curative intent
- At least 4 weeks for patients treated with palliative intent
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other concurrent malignancies except basal cell carcinoma of the skin
- No mental impairment that would preclude completion of questionnaire
- No psychological, familial, sociological, or geographical condition that would
preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
psychometric validity of the STO22 module
Outcome Description:
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.
Outcome Time Frame:
The EORTC QLQ-C30 and the gastric cancer module (QLQ-STO22) will be prospectively administered once before and once after primary treatment.
Safety Issue:
No
Principal Investigator
Jane Blazeby, MB, CHB, FRCS, BSc, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospitals Bristol NHS Trust
Authority:
United States: Federal Government
Study ID:
EORTC-15001-40003
NCT ID:
NCT00020826
Start Date:
April 2001
Completion Date:
January 2004
Related Keywords:
- Gastric Cancer
- adenocarcinoma of the stomach
- Stomach Neoplasms
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