NCT00454376

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

Clinical and Psychometric Validation of a Disease-Specific Questionnaire Module in Assessing the Quality of Life of Patients With G.I.-Related Neuroendocrine Tumours

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 408 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Carcinoid Tumor
• Islet Cell Tumor
• Lung Cancer
• Metastatic Cancer
• Neoplastic Syndrome

Interventions

Type	Name	Description
OTHER	questionnaire administration
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2006-10-01
• First posted: 2007-03-30
• Last updated: 2013-10-29

Locations

16 sites across 10 countries: Denmark, Germany, Greece, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom