assessing quality of life of patients with stomach cancer

Conditions: Gastric Cancer

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.

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.

Eligibility 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

Keywords: adenocarcinoma of the stomach