- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00454376
Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors
Clinical and Psychometric Validation of a Disease-Specific Questionnaire Module in Assessing the Quality of Life of Patients With G.I.-Related Neuroendocrine Tumours
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Aarhus, Denmark, DK 8000
- Aarhus Universitetshospital - Aarhus Sygehus
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Berlin, Germany, D-10117
- Charité - Campus Charité Mitte
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Regensburg, Germany, D-93053
- Klinikum der Universitaet Regensburg
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Athens, Greece, 611
- University Athens Alexandras Hospital
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Jerusalem, Israel, 91120
- Hadassah University Hospital
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Verona, Italy, 37129
- Clinical and Experimental Medicine at the University of Verona
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Amsterdam, Netherlands, 1066 CX
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
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Warsaw, Poland, 02-781
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
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Madrid, Spain, 28040
- Hospital Universitario San Carlos
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Uppsala, Sweden, SE-75185
- Uppsala University Hospital
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England
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Basingstoke, England, United Kingdom, RG24 9NA
- Basingstoke and North Hampshire NHS Foundation Trust
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Liverpool, England, United Kingdom, L9 7AL
- Aintree University Hospital
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London, England, United Kingdom, SE5 9RS
- King's College Hospital
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London, England, United Kingdom, NW1 2QG
- UCL Cancer Institute
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Southampton, England, United Kingdom, SO16 6YD
- Southampton General Hospital
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Northern Ireland
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Belfast, Northern Ireland, United Kingdom, BT12 6BA
- Royal Victoria Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
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
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)
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Secondary Outcome Measures
Outcome Measure |
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Response to change after various treatments
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: John K. Ramage, MD, Basingstoke and North Hampshire NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Pancreatic Diseases
- Adenoma
- Pancreatic Neoplasms
- Neoplasms
- Gastrointestinal Neoplasms
- Neuroendocrine Tumors
- Carcinoid Tumor
- Adenoma, Islet Cell
- Malignant Carcinoid Syndrome
Other Study ID Numbers
- CDR0000537344
- EORTC-QLQ-G.I.NET21
- EU-20712
- BNHFT-P4NET
- EU-207101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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