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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Lung Cancer, Metastatic Cancer, Neoplastic Syndrome

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire administration|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to change after various treatments |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, pulmonary carcinoid tumor, gastrinoma, insulinoma, WDHA syndrome, pancreatic polypeptide tumor, somatostatinoma, glucagonoma, liver metastases