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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-03-27
• Study First Submitted QC: 2007-03-27
• Study First Posted: 2007-03-30
• Status Verified: 2008-11
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29

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

Name	Time	Method
Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)

Secondary Outcome Measures

Name	Time	Method
Response to change after various treatments

Trial Locations

Locations (16)

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw; 🇵🇱 Warsaw, Poland

Klinikum der Universitaet Regensburg; 🇩🇪 Regensburg, Germany

Hospital Universitario San Carlos; 🇪🇸 Madrid, Spain

UCL Cancer Institute; 🇬🇧 London, England, United Kingdom

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Clinical and Experimental Medicine at the University of Verona; 🇮🇹 Verona, Italy

University Athens Alexandras Hospital; 🇬🇷 Athens, Greece

Charite - Campus Charite Mitte; 🇩🇪 Berlin, Germany

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital; 🇳🇱 Amsterdam, Netherlands

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel

Southampton General Hospital; 🇬🇧 Southampton, England, United Kingdom

Aarhus Universitetshospital - Aarhus Sygehus; 🇩🇰 Aarhus, Denmark

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