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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00454376
• Other study ID #: CDR0000537344
• Secondary ID: EORTC-QLQ-G.I.NE
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 27, 2007
• Last updated: October 28, 2013
• Start date: October 2006

Study information

• Verified date: November 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 408
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Carcinoid Tumor
• Gastrointestinal Carcinoid Tumor
• Gastrointestinal Neoplasms
• Islet Cell Tumor
• Lung Cancer
• Malignant Carcinoid Syndrome
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplastic Syndrome
• Neuroendocrine Tumors

Intervention

Other:
• questionnaire administration

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
Denmark	Aarhus Universitetshospital - Aarhus Sygehus	Aarhus
Germany	Charite - Campus Charite Mitte	Berlin
Germany	Klinikum der Universitaet Regensburg	Regensburg
Greece	University Athens Alexandras Hospital	Athens
Israel	Hadassah University Hospital	Jerusalem
Italy	Clinical and Experimental Medicine at the University of Verona	Verona
Netherlands	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital	Amsterdam
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw	Warsaw
Spain	Hospital Universitario San Carlos	Madrid
Sweden	Uppsala University Hospital	Uppsala
United Kingdom	Basingstoke and North Hampshire NHS Foundation Trust	Basingstoke	England
United Kingdom	Royal Victoria Hospital	Belfast	Northern Ireland
United Kingdom	Aintree University Hospital	Liverpool	England
United Kingdom	King's College Hospital	London	England
United Kingdom	UCL Cancer Institute	London	England
United Kingdom	Southampton General Hospital	Southampton	England

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

Denmark,  Germany,  Greece,  Israel,  Italy,  Netherlands,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)			No
Secondary	Response to change after various treatments			No