Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454376
Status:
UNKNOWN
Last Update Posted:
2013-10-29
First Post:
2007-03-27
Brief Title:
Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Clinical and Psychometric Validation of a Disease-Specific Questionnaire Module in Assessing the Quality of Life of Patients With GI-Related Neuroendocrine Tumours
Status:
UNKNOWN
Status Verified Date:
2008-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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-GINET21 in patients with gastrointestinal-related neuroendocrine tumors
Secondary
Determine the quality of life of patients using QLQ-C30 and the QLQ-GINET21 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-GINET21 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
Primary
Test the scale structure reliability and validity of the gastrointestinal neuroendocrine tumor module QLQ-GINET21 in patients with gastrointestinal-related neuroendocrine tumors
Secondary
Determine the quality of life of patients using QLQ-C30 and the QLQ-GINET21 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-GINET21 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-207101 | None | None | None |
| EORTC-QLQ-GINET21 | None | None | None |
| EU-20712 | None | None | None |
| BNHFT-P4NET | None | None | None |