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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00454376
First received: March 27, 2007
Last updated: October 28, 2013
Last verified: November 2008
  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 4

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:


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
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, see Learn About Clinical Studies.

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

Locations
Denmark
Aarhus Universitetshospital - Aarhus Sygehus
Aarhus, Denmark, DK 8000
Germany
Charite - Campus Charite Mitte
Berlin, Germany, D-10117
Klinikum der Universitaet Regensburg
Regensburg, Germany, D-93053
Greece
University Athens Alexandras Hospital
Athens, Greece, 611
Israel
Hadassah University Hospital
Jerusalem, Israel, 91120
Italy
Clinical and Experimental Medicine at the University of Verona
Verona, Italy, 37129
Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, Poland, 02-781
Spain
Hospital Universitario San Carlos
Madrid, Spain, 28040
Sweden
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
King's College Hospital
London, England, United Kingdom, SE5 9RS
UCL Cancer Institute
London, England, United Kingdom, NW1 2QG
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Victoria Hospital
Belfast, Northern Ireland, United Kingdom, BT12 6BA
Sponsors and Collaborators
Investigators
Study Chair: John K. Ramage, MD Basingstoke and North Hampshire NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00454376     History of Changes
Other Study ID Numbers: CDR0000537344, EORTC-QLQ-G.I.NET21, EU-20712, BNHFT-P4NET, EU-207101
Study First Received: March 27, 2007
Last Updated: October 28, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoid Tumor
Lung Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neuroendocrine Tumors
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Adenoma
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014