Working… Menu

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. 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
Information provided by:
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.

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

Detailed Description:



  • 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.

Layout table for study information
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

Primary Outcome Measures :
  1. Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)

Secondary Outcome Measures :
  1. Response to change after various treatments

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


  • 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


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00454376

Layout table for location information
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
United Kingdom
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
Sponsors and Collaborators
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: John K. Ramage, MD Basingstoke and North Hampshire NHS Foundation Trust
Layout table for additonal information Identifier: NCT00454376    
Other Study ID Numbers: CDR0000537344
First Posted: March 30, 2007    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: November 2008
Keywords provided by National Cancer Institute (NCI):
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
pulmonary carcinoid tumor
WDHA syndrome
pancreatic polypeptide tumor
liver metastases
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Carcinoid Tumor
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases