Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors
- Conditions
- Gastrointestinal Carcinoid TumorIslet Cell TumorLung CancerMetastatic CancerNeoplastic Syndrome
- Registration Number
- NCT00454376
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 408
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)
- Secondary Outcome Measures
Name Time Method Response to change after various treatments
Trial Locations
- Locations (16)
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
Scroll for more (6 remaining)Aarhus Universitetshospital - Aarhus Sygehus🇩🇰Aarhus, Denmark