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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00454376
Recruitment Status : Unknown
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : March 30, 2007
Last Update Posted : October 29, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date March 27, 2007
First Posted Date March 30, 2007
Last Update Posted Date October 29, 2013
Study Start Date October 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: March 27, 2007)
Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 27, 2007)
Response to change after various treatments
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Tumor
  • Lung Cancer
  • Metastatic Cancer
  • Neoplastic Syndrome
Intervention
  • Other: questionnaire administration
  • Procedure: quality-of-life assessment
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 27, 2007)
408
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark,   Germany,   Greece,   Israel,   Italy,   Netherlands,   Poland,   Spain,   Sweden,   United Kingdom
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00454376
Other Study ID Numbers CDR0000537344
EORTC-QLQ-G.I.NET21
EU-20712
BNHFT-P4NET
EU-207101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Cancer Institute (NCI)
Collaborators Not Provided
Investigators
Study Chair: John K. Ramage, MD Basingstoke and North Hampshire NHS Foundation Trust
PRS Account National Cancer Institute (NCI)
Verification Date November 2008