disease-specific questionnaire in assessing quality of life in patients with gastrointestinal-related neuroendocrine tumors

Conditions: Gastrointestinal Carcinoid Tumor; Islet Cell Tumor; Lung Cancer; Metastatic Cancer; Neoplastic Syndrome

Summary: rationale: questionnaires that measure quality of life may help doctors identify the effects of treatment and improve the ability to plan treatment for patients with gastrointestinal-related neuroendocrine tumors. purpose: this phase iv clinical trial is studying how well a disease-specific questionnaire works in assessing the quality of life of patients with gastrointestinal-related neuroendocrine tumors.

objectives: primary * test the scale structure, reliability, and validity of the gastrointestinal neuroendocrine tumor module (qlq-g.i.net21) in patients with gastrointestinal-related neuroendocrine tumors. secondary * determine the quality of life of patients using qlq-c30 and the qlq-g.i.net21 before and after treatment. outline: this is a multicenter study. patients are stratified according to treatment (somatostatin analogue therapy or interferon therapy vs radionuclide therapy or chemotherapy vs ablative therapies \[embolization or radiofrequency ablation\] or liver resection). patients complete the eortc c30 questionnaire, qlq-g.i.net21 module, and are evaluated for karnofsky performance status at pretreatment, at 3 and 6 months after treatment, and then 2 weeks later. patients also complete a clinical data and sociodemographic data form and debriefing questionnaire at pretreatment; a follow-up form at 3 months and 6 months after treatment; and a test-retest form 2 weeks later. projected accrual: a total of 408 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed neuroendocrine tumor or characteristic radiological findings of neuroendocrine tumor with raised hormone levels in plasma or urine meeting any of the following criteria: * primary disease in gut with liver metastases (with or without hormone secretion) * primary disease in lung with liver or abdominal metastases (with or without hormone secretion) * primary disease in pancreas with or without metastases (with or without hormone secretion) patient characteristics: * any karnofsky performance status allowed * life expectancy ≥ 3 months * able to understand the questionnaire language * mentally fit to complete questionnaire * no psychological, familial, sociological, or geographical condition that would limit study compliance * no other concurrent malignancies except basal cell carcinoma of the skin prior concurrent therapy: * more than 2 months since prior somatostatin analogue or interferon therapy (somatostatin therapy stratum) * concurrent somatostatin analogue and/or interferon therapy allowed if dose stable over the past month * more than 6 months since prior radionuclide therapy or systemic chemotherapy (radionuclide or systemic chemotherapy stratum) * more than 6 months since prior ablative therapies (ablative therapy stratum) * no concurrent participation in other quality of life studies

Keywords: metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor pulmonary carcinoid tumor gastrinoma insulinoma wdha syndrome pancreatic polypeptide tumor somatostatinoma glucagonoma liver metastases