Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Lung Cancer, Metastatic Cancer, Neoplastic Syndrome
Conditions
Keywords
metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, pulmonary carcinoid tumor, gastrinoma, insulinoma, WDHA syndrome, pancreatic polypeptide tumor, somatostatinoma, glucagonoma, liver metastases
Brief 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.
Detailed description
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.
Interventions
OTHERquestionnaire administration
PROCEDUREquality-of-life assessment
Sponsors
National Cancer Institute (NCI)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response to change after various treatments | — |
Countries
Denmark, Germany, Greece, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
Outcome results
None listed