Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00454376|
Recruitment Status : Unknown
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : March 30, 2007
Last Update Posted : October 29, 2013
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.
|Condition or disease||Intervention/treatment|
|Gastrointestinal Carcinoid Tumor Islet Cell Tumor Lung Cancer Metastatic Cancer Neoplastic Syndrome||Other: questionnaire administration Procedure: quality-of-life assessment|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||408 participants|
|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|
|Study Start Date :||October 2006|
- Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)
- Response to change after various treatments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|UCL Cancer Institute|
|London, England, United Kingdom, NW1 2QG|
|King's College Hospital|
|London, England, United Kingdom, SE5 9RS|
|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|