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

NCT00454376 | Unknown

• 5 other identifiers: CDR0000537344EORTC-QLQ-G.I.NET21EU-20712BNHFT-P4NETEU-207101
• Study Type: observational
• Target: 408
• Locations: 10 countries
• Sites: 16

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.

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

Outcome Measures

Primary Outcomes (1)

• Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)

Secondary Outcomes (1)

• Response to change after various treatments

Interventions

questionnaire administration OTHER

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (16)

Aarhus Universitetshospital - Aarhus Sygehus

Aarhus, DK 8000, Denmark

Location

Charite - Campus Charite Mitte

Berlin, D-10117, Germany

Location

Klinikum der Universitaet Regensburg

Regensburg, D-93053, Germany

Location

University Athens Alexandras Hospital

Athens, 611, Greece

Location

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

Clinical and Experimental Medicine at the University of Verona

Verona, 37129, Italy

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw

Warsaw, 02-781, Poland

Location

Hospital Universitario San Carlos

Madrid, 28040, Spain

Location

Uppsala University Hospital

Uppsala, SE-75185, Sweden

Location

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, RG24 9NA, United Kingdom

Location

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

UCL Cancer Institute

London, England, NW1 2QG, United Kingdom

Location

King's College Hospital

London, England, SE5 9RS, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Victoria Hospital

Belfast, Northern Ireland, BT12 6BA, United Kingdom

Location

MeSH Terms

Conditions

Adenoma, Islet Cell; Lung Neoplasms; Neoplasm Metastasis; Neoplasms; Gastrinoma; Insulinoma; Vipoma; Somatostatinoma; Glucagonoma

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Islet Cell; Adenocarcinoma; Carcinoma; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal

Study Officials

• John K. Ramage, MD

  Basingstoke and North Hampshire NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 30, 2007
• Study Start: October 1, 2006
• Last Updated: October 29, 2013

Record last verified: 2008-11

Locations

ES (1); DE (2); DK (1); IL (1); IT (1); NL (1); SE (1); GR (1); GB (6); PL (1)