Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003772
Status:
COMPLETED
Last Update Posted:
2012-08-27
First Post:
1999-11-01
Brief Title:
Quality-of-Life Assessment in Patients With Ovarian Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
An International Field Study of the Reliability and Validity of a Disease-Specific Questionnaire Module the QLQ-OV28 in Assessing the Quality of Life of Patients With Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
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 Quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment
PURPOSE This clinical trial studies the quality of life in patients with ovarian cancer
PURPOSE This clinical trial studies the quality of life in patients with ovarian cancer
Detailed Description:
OBJECTIVES I Evaluate the scale structure and reliability of the ovarian cancer specific questionnaire module EORTC QLQ-OV28 designed to be used in conjunction with the standard nonspecific questionnaire EORTC QLQ-C30 in patients with ovarian epithelial cancer II Evaluate the psychometric properties of the revised scales physical and role functioning global health statusQL of the EORTC QLQ-C30 among ovarian cancer patients III Evaluate the evidence for the validity of EORTC QLQ-OV28
OUTLINE This is a multicenter study Patients are stratified according to prior therapy and disease Questionnaires are designed to be completed by patients themselves without help Patients complete the EORTC QLQ-C30 QLQ-OV28 and a debriefing questionnaire regarding time to completion and patients reaction to the quality of life questionnaires according to one of the following schedules Group 1 Patients complete the questionnaires once prior to the start of the first course of chemotherapy and again on the first day of the third course of chemotherapy Group 2 Patients complete the questionnaires once 1 to 8 weeks following completion of the 6th course of chemotherapy and prior to any further anticancer therapy Group 3 Patients complete the questionnaires once at a routine follow-up clinic visit and again at home within 3 days of the clinic visit Group 4 Patients complete the questionnaires once prior to the first course of chemotherapy and again on the first day of the 3rd course of chemotherapy prior to administration OR at the first clinical review following 2 courses of chemotherapy OR 2 months later for patients receiving continuous or weekly chemotherapy If they are unable to complete written questionnaires due to physical limitations or illiteracy or if they express a strong preference for oral administration patients in Groups 1 2 and 4 may complete the questionnaires orally instead
PROJECTED ACCRUAL A minimum of 280 patients will be accrued for this study within 2 years
OUTLINE This is a multicenter study Patients are stratified according to prior therapy and disease Questionnaires are designed to be completed by patients themselves without help Patients complete the EORTC QLQ-C30 QLQ-OV28 and a debriefing questionnaire regarding time to completion and patients reaction to the quality of life questionnaires according to one of the following schedules Group 1 Patients complete the questionnaires once prior to the start of the first course of chemotherapy and again on the first day of the third course of chemotherapy Group 2 Patients complete the questionnaires once 1 to 8 weeks following completion of the 6th course of chemotherapy and prior to any further anticancer therapy Group 3 Patients complete the questionnaires once at a routine follow-up clinic visit and again at home within 3 days of the clinic visit Group 4 Patients complete the questionnaires once prior to the first course of chemotherapy and again on the first day of the 3rd course of chemotherapy prior to administration OR at the first clinical review following 2 courses of chemotherapy OR 2 months later for patients receiving continuous or weekly chemotherapy If they are unable to complete written questionnaires due to physical limitations or illiteracy or if they express a strong preference for oral administration patients in Groups 1 2 and 4 may complete the questionnaires orally instead
PROJECTED ACCRUAL A minimum of 280 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-15982 | OTHER | EORTC | None |