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

October 28, 2013 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

408

Contacts and Locations

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

Study Locations

  • Denmark
      • Aarhus, Denmark, DK 8000
        • Aarhus Universitetshospital - Aarhus Sygehus
  • Germany
      • Berlin, Germany, D-10117
        • Charité - Campus Charité Mitte
      • Regensburg, Germany, D-93053
        • Klinikum der Universitaet Regensburg
  • Greece
      • Athens, Greece, 611
        • University Athens Alexandras Hospital
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital
  • Italy
      • Verona, Italy, 37129
        • Clinical and Experimental Medicine at the University of Verona
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
  • Poland
      • Warsaw, Poland, 02-781
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
  • Spain
      • Madrid, Spain, 28040
        • Hospital Universitario San Carlos
  • Sweden
      • Uppsala, Sweden, SE-75185
        • Uppsala University Hospital
  • United Kingdom
    • England
      • Basingstoke, England, United Kingdom, RG24 9NA
        • Basingstoke and North Hampshire NHS Foundation Trust
      • Liverpool, England, United Kingdom, L9 7AL
        • Aintree University Hospital
      • London, England, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, England, United Kingdom, NW1 2QG
        • UCL Cancer Institute
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT12 6BA
        • Royal Victoria Hospital

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Response to change after various treatments

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

Investigators

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

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 Major Dates

Study Start

October 1, 2006

Study Registration Dates

First Submitted

March 27, 2007

First Submitted That Met QC Criteria

March 27, 2007

First Posted (Estimate)

March 30, 2007

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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