Long-Term Effects of Treatment in Patients Previously Treated for Childhood Hodgkin's Lymphoma
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Purpose
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 | Intervention |
|---|---|
|
Long-term Effects Secondary to Cancer Therapy in Children Lymphoma |
Other: medical chart review Other: questionnaire administration Procedure: management of therapy complications |
| Study Type: | Observational |
| Official Title: | Health-Related Outcomes For Hodgkin's Disease Survivors |
| Estimated Enrollment: | 1000 |
| Study Start Date: | December 2004 |
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 Hodgkin's 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 Hodgkin's 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 Children's 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 1,000 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Contemporary cohort
At least 5 years since diagnosis of Hodgkin's lymphoma
- Diagnosed between the years 1987-2001
- 21 and under at diagnosis
- No evidence of disease
Prior treatment on 1 of the following protocols during the years 1987-2001:
- Children's Cancer Group (CCG) CCG-5942, CCG-59704
- Pediatric Oncology Group (POG) POG-8625, POG-8725, POG-9425, POG-9426
- Pediatric Hodgkin's Consortium: VAMP, VEPA, VAMP/COP
- Institutional protocols COPP/ABV, MOPP/ABVD, ABVD
Childhood Cancer Survivor Study (CCSS) Hodgkin's lymphoma cohort
- Current enrollment in the CCSS
- Diagnosed between the years 1976-1986
- 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| United States, California | |
| Lucile Packard Children's Hospital at Stanford University Medical Center | |
| Palo Alto, California, United States, 95798 | |
| United States, Connecticut | |
| Yale Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, New Jersey | |
| Hackensack University Medical Center Cancer Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-9786 | |
| United States, Rhode Island | |
| Rhode Island Hospital Comprehensive Cancer Center | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| United States, Wisconsin | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Principal Investigator: | Debra L. Friedman, MD, MS | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00091091 History of Changes |
| Other Study ID Numbers: | CDR0000383244, COG-ALTE04N1 |
| Study First Received: | September 7, 2004 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
long-term effects secondary to cancer therapy in children stage I childhood Hodgkin lymphoma stage II childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013