Back to resultsDisease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors
Primary Purpose
Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Lung Cancer
Status
Unknown status
Phase
Locations
International
Study Type
Observational
Intervention
questionnaire administration
quality-of-life assessment
Sponsored by
About this trial
This is an observational trial for Gastrointestinal Carcinoid Tumor focused on measuring metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, pulmonary carcinoid tumor, gastrinoma, insulinoma, WDHA syndrome, pancreatic polypeptide tumor, somatostatinoma, glucagonoma, liver metastases
Eligibility 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
Sites / Locations
- Aarhus Universitetshospital - Aarhus Sygehus
- Charite - Campus Charite Mitte
- Klinikum der Universitaet Regensburg
- University Athens Alexandras Hospital
- Hadassah University Hospital
- Clinical and Experimental Medicine at the University of Verona
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
- Hospital Universitario San Carlos
- Uppsala University Hospital
- Basingstoke and North Hampshire NHS Foundation Trust
- Aintree University Hospital
- UCL Cancer Institute
- King's College Hospital
- Southampton General Hospital
- Royal Victoria Hospital
Outcomes
Primary Outcome Measures
Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)
Secondary Outcome Measures
Response to change after various treatments
Full Information
NCT ID
NCT00454376
First Posted
March 27, 2007
Last Updated
October 28, 2013
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00454376
Brief Title
Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors
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 Type
Observational
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Lung Cancer, Metastatic Cancer, Neoplastic Syndrome
Keywords
metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, pulmonary carcinoid tumor, gastrinoma, insulinoma, WDHA syndrome, pancreatic polypeptide tumor, somatostatinoma, glucagonoma, liver metastases
7. Study Design
Enrollment
408 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)
Secondary Outcome Measure Information:
Title
Response to change after various treatments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John K. Ramage, MD
Organizational Affiliation
Basingstoke and North Hampshire NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus Universitetshospital - Aarhus Sygehus
City
Aarhus
ZIP/Postal Code
DK 8000
Country
Denmark
Facility Name
Charite - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Klinikum der Universitaet Regensburg
City
Regensburg
ZIP/Postal Code
D-93053
Country
Germany
Facility Name
University Athens Alexandras Hospital
City
Athens
ZIP/Postal Code
611
Country
Greece
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Clinical and Experimental Medicine at the University of Verona
City
Verona
ZIP/Postal Code
37129
Country
Italy
Facility Name
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
SE-75185
Country
Sweden
Facility Name
Basingstoke and North Hampshire NHS Foundation Trust
City
Basingstoke
State/Province
England
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
UCL Cancer Institute
City
London
State/Province
England
ZIP/Postal Code
NW1 2QG
Country
United Kingdom
Facility Name
King's College Hospital
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Victoria Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
12. IPD Sharing Statement
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Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors
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