Gastric Cancer
Conditions
Keywords
adenocarcinoma of the stomach
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.
Interventions
OTHERquality-of-life assessment
QLQ-C30 questionnaire administered. STO22 questionnaire administered.
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| compliance | at the same timepoints when the QoL questionnaires are completed | Proportion of completed versus expected QoL questionnaires |
| correlation between QLQ-C30 and STO22 scores | before and after treatment | correlations between the different established scales of the QLQ-C30 and the hypothesized STO22 scales will be calculated. |
Countries
France, Germany, Spain, Sweden, United Kingdom
Outcome results
None listed