Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors
Recruitment status was Active, not recruiting
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.
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Other: questionnaire administration
Procedure: quality-of-life assessment
|Official Title:||Clinical and Psychometric Validation of a Disease-Specific Questionnaire Module in Assessing the Quality of Life of Patients With G.I.-Related Neuroendocrine Tumours|
- Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21) [ Designated as safety issue: No ]
- Response to change after various treatments [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
- Test the scale structure, reliability, and validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21) in patients with gastrointestinal-related neuroendocrine tumors.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454376
|Aarhus Universitetshospital - Aarhus Sygehus|
|Aarhus, Denmark, DK 8000|
|Charite - Campus Charite Mitte|
|Berlin, Germany, D-10117|
|Klinikum der Universitaet Regensburg|
|Regensburg, Germany, D-93053|
|University Athens Alexandras Hospital|
|Athens, Greece, 611|
|Hadassah University Hospital|
|Jerusalem, Israel, 91120|
|Clinical and Experimental Medicine at the University of Verona|
|Verona, Italy, 37129|
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital|
|Amsterdam, Netherlands, 1066 CX|
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw|
|Warsaw, Poland, 02-781|
|Hospital Universitario San Carlos|
|Madrid, Spain, 28040|
|Uppsala University Hospital|
|Uppsala, Sweden, SE-75185|
|Basingstoke and North Hampshire NHS Foundation Trust|
|Basingstoke, England, United Kingdom, RG24 9NA|
|Aintree University Hospital|
|Liverpool, England, United Kingdom, L9 7AL|
|King's College Hospital|
|London, England, United Kingdom, SE5 9RS|
|UCL Cancer Institute|
|London, England, United Kingdom, NW1 2QG|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Royal Victoria Hospital|
|Belfast, Northern Ireland, United Kingdom, BT12 6BA|
|Study Chair:||John K. Ramage, MD||Basingstoke and North Hampshire NHS Foundation Trust|