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

Conditions
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Lung Cancer
Metastatic Cancer
Neoplastic Syndrome
Registration Number
NCT00454376
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
408
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)
Secondary Outcome Measures
NameTimeMethod
Response to change after various treatments

Trial Locations

Locations (16)

Aarhus Universitetshospital - Aarhus Sygehus

🇩🇰

Aarhus, Denmark

Charite - Campus Charite Mitte

🇩🇪

Berlin, Germany

Klinikum der Universitaet Regensburg

🇩🇪

Regensburg, Germany

University Athens Alexandras Hospital

🇬🇷

Athens, Greece

Hadassah University Hospital

🇮🇱

Jerusalem, Israel

Clinical and Experimental Medicine at the University of Verona

🇮🇹

Verona, Italy

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

🇳🇱

Amsterdam, Netherlands

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw

🇵🇱

Warsaw, Poland

Hospital Universitario San Carlos

🇪🇸

Madrid, Spain

Uppsala University Hospital

🇸🇪

Uppsala, Sweden

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Aarhus Universitetshospital - Aarhus Sygehus
🇩🇰Aarhus, Denmark

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