Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005881
Status:
COMPLETED
Last Update Posted:
2013-08-23
First Post:
2000-06-02
Brief Title:
Quality of Life in Children Treated for Cancer
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Assessment of HealthQuality of Life in Survivors of Childhood Cancer
Status:
COMPLETED
Status Verified Date:
2013-08
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 Questionnaires that measure quality of life may improve the ability to plan treatment for children with cancer
PURPOSE This randomized clinical trial is studying the quality of life in children treated for cancer
PURPOSE This randomized clinical trial is studying the quality of life in children treated for cancer
Detailed Description:
OBJECTIVES I Assess the validity and reliability of a quality of life questionnaire MM-QOL that is being developed for patients with previously or currently treated childhood cancers
OUTLINE This is a randomized multicenter study Patients are stratified according to age 8-12 vs 13-20 and treatment current vs previous Patients are randomized to one of two arms of the study Arm I Reliability Patients will complete the same questionnaire two weeks apart age 13-20 stratum closed as of 71400 Arm II Validity Patients will complete a study questionnaire plus a Child Health Questionnaire Patients between ages 8-12 are interviewed and patients between ages 13-20 complete a written questionnaire
PROJECTED ACCRUAL A total of 716 patients 416 for arm I 208 for 8-12 age group and 208 for 13-20 age group and 300 for arm II 150 for 8-12 age group and 150 for 13-20 age group will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified according to age 8-12 vs 13-20 and treatment current vs previous Patients are randomized to one of two arms of the study Arm I Reliability Patients will complete the same questionnaire two weeks apart age 13-20 stratum closed as of 71400 Arm II Validity Patients will complete a study questionnaire plus a Child Health Questionnaire Patients between ages 8-12 are interviewed and patients between ages 13-20 complete a written questionnaire
PROJECTED ACCRUAL A total of 716 patients 416 for arm I 208 for 8-12 age group and 208 for 13-20 age group and 300 for arm II 150 for 8-12 age group and 150 for 13-20 age group will be accrued for this study
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 |
|---|---|---|---|
| CDR0000067920 | OTHER | Clinical Trialsgov | None |
| CCG-AS972 | OTHER | None | None |
| CCG-S9702 | OTHER | None | None |
| NCI-P00-0148 | OTHER | None | None |