Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors - Full Text View

Sponsored by:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00454376

Purpose

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	Intervention	Phase
Gastrointestinal Carcinoid Tumor Islet Cell Tumor Lung Cancer Metastatic Cancer Neoplastic Syndrome	Other: questionnaire administration Procedure: quality-of-life assessment	Phase IV

Study Type:	Observational
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Carcinoid Tumors Lung Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response to change after various treatments [ Designated as safety issue: No ]

Estimated Enrollment:	408
Study Start Date:	October 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454376

Locations

Denmark
Aarhus Universitetshospital - Aarhus Sygehus	Recruiting
Aarhus, Denmark, DK 8000
Contact: Contact Person 45-89-49-2555
Germany
Charite - Campus Charite Mitte	Recruiting
Berlin, Germany, D-10117
Contact: Contact Person 49-304-5050
Klinikum der Universitaet Regensburg	Recruiting
Regensburg, Germany, D-93053
Contact: Contact Person 49-941-7047-7110
Greece
University Athens Alexandras Hospital	Recruiting
Athens, Greece, 611
Contact: Contact Person 30-210-77-0802
Israel
Hadassah University Hospital	Recruiting
Jerusalem, Israel, 91120
Contact: Contact Person 972-26-777-111
Italy
Clinical and Experimental Medicine at the University of Verona	Recruiting
Verona, Italy, 37129
Contact: Contact Person 39-045-802-7155
Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital	Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Contact Person 31-20-512-9111
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw	Recruiting
Warsaw, Poland, 02-781
Contact: Contact Person 48-22-644-7625
Spain
Hospital Universitario San Carlos	Recruiting
Madrid, Spain, 28040
Contact: Contact Person 34-91-330-3000
Sweden
Uppsala University Hospital	Recruiting
Uppsala, Sweden, SE-75185
Contact: Contact Person 46-18-611-0000
United Kingdom, England
Aintree University Hospital	Recruiting
Liverpool, England, United Kingdom, L9 7AL
Contact: Contact Person 44-151-525-5980
Basingstoke and North Hampshire NHS Foundation Trust	Recruiting
Basingstoke, England, United Kingdom, RG24 9NA
Contact: Contact Person 44-125-647-3202
King's College Hospital	Recruiting
London, England, United Kingdom, SE5 9RS
Contact: Contact Person 44-20-3299-9000
Southampton General Hospital	Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Contact Person 44-23-8077-7222
UCL Cancer Institute	Recruiting
London, England, United Kingdom, NW1 2QG
Contact: Contact Person 44-20-7794-0500
United Kingdom, Northern Ireland
Royal Victoria Hospital	Recruiting
Belfast, Northern Ireland, United Kingdom, BT12 6BA
Contact: Contact Person 44-28-9063-2515

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Study Chair:

John K. Ramage, MD

Basingstoke and North Hampshire NHS Foundation Trust

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000537344, EORTC-QLQ-G.I.NET21, EU-20712
Study First Received:	March 27, 2007
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00454376 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
pulmonary carcinoid tumor
gastrinoma
insulinoma

WDHA syndrome
pancreatic polypeptide tumor
somatostatinoma
glucagonoma
liver metastases

Study placed in the following topic categories:

Thoracic Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Pancreatic Polypeptide
Quality of Life
Respiratory Tract Diseases
Lung Neoplasms
Zollinger-Ellison Syndrome
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Neuroepithelioma
Endocrine Gland Neoplasms
Carcinoid Syndrome
Pancreatic Islet Cell Tumors
Digestive System Neoplasms

Serotonin Syndrome
Insulinoma
Endocrine System Diseases
Adenoma, Islet Cell
Malignant Carcinoid Syndrome
Recurrence
Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors
Gastrinoma
Digestive System Diseases
Lung Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Carcinoid Tumor

Additional relevant MeSH terms:

Thoracic Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Neoplasms, Nerve Tissue
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Syndrome
Neoplasm Metastasis
Endocrine Gland Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type

Disease
Digestive System Neoplasms
Endocrine System Diseases
Adenoma, Islet Cell
Malignant Carcinoid Syndrome
Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors
Neoplasms
Digestive System Diseases
Lung Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Carcinoid Tumor
Adenocarcinoma

ClinicalTrials.gov processed this record on September 10, 2009