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
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.
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.
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