Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors
NCT ID: NCT00454376
Last Updated: 2013-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
408 participants
OBSERVATIONAL
2006-10-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Interventions
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questionnaire administration
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Principal Investigators
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John K. Ramage, MD
Role: STUDY_CHAIR
Basingstoke and North Hampshire NHS Foundation Trust
Locations
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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
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom
Aintree University Hospital
Liverpool, England, United Kingdom
UCL Cancer Institute
London, England, United Kingdom
King's College Hospital
London, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Victoria Hospital
Belfast, Northern Ireland, United Kingdom
Countries
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Other Identifiers
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EORTC-QLQ-G.I.NET21
Identifier Type: -
Identifier Source: secondary_id
EU-20712
Identifier Type: -
Identifier Source: secondary_id
BNHFT-P4NET
Identifier Type: -
Identifier Source: secondary_id
EU-207101
Identifier Type: -
Identifier Source: secondary_id
CDR0000537344
Identifier Type: -
Identifier Source: org_study_id