Long-Term Effects of Treatment in Patients Previously Treated for Childhood Hodgkin's Lymphoma
Study Details
Study Description
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 Hodgkin's lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
OBJECTIVES:
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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 Hodgkin's lymphoma.
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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 Hodgkin's lymphoma survivors from the Childhood Cancer Survivor Study (CCSS).
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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.
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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 Children's Oncology Group Late Effects Screening Guidelines and the patients' specific therapeutic exposures.
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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 1,000 patients will be accrued for this study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All patients Self report/Medical record review/ clinical eval |
Other: medical chart review
Other: questionnaire administration
Procedure: management of therapy complications
|
Outcome Measures
Primary Outcome Measures
- Risk for a specific adverse condition until the earliest of death, development of the adverse condition, loss to follow up, or completion of questionnaire [length of study]
The calculation of the incidence rates will be done in two ways: (a) using the self-report incidence of adverse conditions; and (b) using the incidence of adverse conditions validated by clinical evaluation.
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Contemporary cohort
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At least 5 years since diagnosis of Hodgkin's lymphoma
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Diagnosed between the years 1987-2001
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21 and under at diagnosis
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No evidence of disease
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Prior treatment on 1 of the following protocols during the years 1987-2001:
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Children's Cancer Group (CCG) CCG-5942, CCG-59704
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Pediatric Oncology Group (POG) POG-8625, POG-8725, POG-9425, POG-9426
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Pediatric Hodgkin's Consortium: VAMP, VEPA, VAMP/COP
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Institutional protocols COPP/ABV, MOPP/ABVD, ABVD
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Childhood Cancer Survivor Study (CCSS) Hodgkin's lymphoma cohort
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Current enrollment in the CCSS
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Diagnosed between the years 1976-1986
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Completed baseline questionnaire at comparable timepoints (as the contemporary cohort) after diagnosis
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto | California | United States | 95798 |
| 2 | Yale Cancer Center | New Haven | Connecticut | United States | 06520-8028 |
| 3 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60637-1470 |
| 4 | Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | United States | 07601 |
| 5 | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | United States | 10032 |
| 6 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
| 7 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 8 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229-3039 |
| 9 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104-9786 |
| 10 | Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | United States | 02903 |
| 11 | St. Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
| 12 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6838 |
| 13 | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | United States | 75390 |
| 14 | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | United States | 98105 |
| 15 | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | United States | 54307-3508 |
Sponsors and Collaborators
- Children's Oncology Group
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Debra L. Friedman, MD, MS, Vanderbilt-Ingram Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALTE04N1
- COG-ALTE04N1
- CDR0000383244
- NCI-2009-00381