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.
Study Type
OBSERVATIONAL
Enrollment
408
Aarhus Universitetshospital - Aarhus Sygehus
Aarhus, Denmark
Charite - Campus Charite Mitte
Berlin, Germany
Klinikum der Universitaet Regensburg
Regensburg, Germany
University Athens Alexandras Hospital
Athens, Greece
Hadassah University Hospital
Jerusalem, Israel
Clinical and Experimental Medicine at the University of Verona
Verona, Italy
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, Poland
Hospital Universitario San Carlos
Madrid, Spain
Uppsala University Hospital
Uppsala, Sweden
...and 6 more locations
Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)
Response to change after various treatments
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