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

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.

Intervention(s) in this Clinical Trial

• Other: questionnaire administration
• Procedure: quality-of-life assessment

Primary Measures

• Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)
  • Safety Issue?: No

Secondary Measures

• Response to change after various treatments
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: European Organization for Research and Treatment of Cancer - EORTC Other

Overall Clinical Trial Officials and Contacts

John K. Ramage, MD Study Chair Basingstoke and North Hampshire NHS Foundation Trust  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00454376

Study ID Number: CDR0000537344

ClinicalTrials.gov Identifier: NCT00454376

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database