Clinical trial NCT00454376: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Lung Cancer
Metastatic Cancer
Neoplastic Syndrome
Keywords: metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
pulmonary carcinoid tumor
gastrinoma
insulinoma
WDHA syndrome
pancreatic polypeptide tumor
somatostatinoma
glucagonoma
liver metastases
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-03-30
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)
Secondary outcomes:
measure: Response to change after various treatments
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital - Aarhus Sygehus
city: Berlin
country: Germany
facility: Charite - Campus Charite Mitte
city: Regensburg
country: Germany
facility: Klinikum der Universitaet Regensburg
city: Athens
country: Greece
facility: University Athens Alexandras Hospital
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Verona
country: Italy
facility: Clinical and Experimental Medicine at the University of Verona
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire NHS Foundation Trust
state: England
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
state: England
city: London
country: United Kingdom
facility: UCL Cancer Institute
state: England
city: London
country: United Kingdom
facility: King's College Hospital
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
state: Northern Ireland
Study officials:
affiliation: Basingstoke and North Hampshire NHS Foundation Trust
name: John K. Ramage, MD
role: STUDY_CHAIR
References: