Disease-Specific Questionnaire In Assessing Quality Of Life In Patients With Gastrointestinal-Related Neuroendocrine Tumors

Study Overview

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

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.

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

OTHER: questionnaire administration
PROCEDURE: quality-of-life assessment

CDR0000537344
EORTC-QLQ-G.I.NET21
EU-20712
BNHFT-P4NET
EU-207101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-03-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-10-28
First Submitted that Met QC Criteria 2007-03-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-10-29
First Posted (ESTIMATED) 2007-03-30	Results First Posted N/A	Last Verified 2008-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

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

Secondary Outcome Measures	Measure Description	Time Frame
Response to change after various treatments

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: John K. Ramage, MD, Basingstoke and North Hampshire NHS Foundation Trust

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record