Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091091
Status:
COMPLETED
Last Update Posted:
2018-07-16
First Post:
2004-09-07
Brief Title:
Long-Term Effects of Treatment in Patients Previously Treated for Childhood Hodgkins Lymphoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Health-Related Outcomes For Hodgkins Disease Survivors
Status:
COMPLETED
Status Verified Date:
2017-02
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 Assessing the long-term effects of cancer treatment in cancer survivors may help improve the ability to plan effective treatment and follow-up care
PURPOSE This clinical trial is studying the long-term effects of treatment in patients who were previously treated for childhood Hodgkins lymphoma
PURPOSE This clinical trial is studying the long-term effects of treatment in patients who were previously treated for childhood Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the cumulative incidence and characterize the spectrum of selected adverse physiologic and psychosocial outcomes using self-report and clinical evaluation in patients previously treated for childhood Hodgkins lymphoma
Compare the cumulative incidence and spectrum of self-reported adverse outcomes of these patients using data collected at a comparable time period after diagnosis with Hodgkins lymphoma survivors from the Childhood Cancer Survivor Study CCSS
Compare self-reported health-related outcomes with outcomes detected by clinical evaluation and medical record review of each group of patients
OUTLINE This is a cohort cross-sectional multicenter study
Contemporary group Patients complete a self-report of long-term outcomes questionnaire and a comprehensive psychosocial questionnaire A medical record review is then performed Patients then undergo a comprehensive risk-based clinical evaluation with specific examinations and studies based upon the Childrens Oncology Group Late Effects Screening Guidelines and the patients specific therapeutic exposures
Childhood Cancer Survivor Study CCSS group Patients undergo a telephone interview and have medical records reviewed to validate select self-reported long-term outcomes Patient replies from the baseline CCSS questionnaire which was completed at certain timepoints after diagnosis are reviewed for targeted long-term outcomes
PROJECTED ACCRUAL Approximately 1000 patients will be accrued for this study
Determine the cumulative incidence and characterize the spectrum of selected adverse physiologic and psychosocial outcomes using self-report and clinical evaluation in patients previously treated for childhood Hodgkins lymphoma
Compare the cumulative incidence and spectrum of self-reported adverse outcomes of these patients using data collected at a comparable time period after diagnosis with Hodgkins lymphoma survivors from the Childhood Cancer Survivor Study CCSS
Compare self-reported health-related outcomes with outcomes detected by clinical evaluation and medical record review of each group of patients
OUTLINE This is a cohort cross-sectional multicenter study
Contemporary group Patients complete a self-report of long-term outcomes questionnaire and a comprehensive psychosocial questionnaire A medical record review is then performed Patients then undergo a comprehensive risk-based clinical evaluation with specific examinations and studies based upon the Childrens Oncology Group Late Effects Screening Guidelines and the patients specific therapeutic exposures
Childhood Cancer Survivor Study CCSS group Patients undergo a telephone interview and have medical records reviewed to validate select self-reported long-term outcomes Patient replies from the baseline CCSS questionnaire which was completed at certain timepoints after diagnosis are reviewed for targeted long-term outcomes
PROJECTED ACCRUAL Approximately 1000 patients 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 |
|---|---|---|---|
| CDR0000383244 | OTHER | None | None |
| COG-ALTE04N1 | OTHER | None | None |
| NCI-2009-00381 | REGISTRY | CTRP Clinical Trial Reporting Program | None |