Long-Term Effects of Treatment in Patients Previously Treated for Childhood Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00091091|
Recruitment Status : Completed
First Posted : September 8, 2004
Last Update Posted : February 14, 2017
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|
|Long-term Effects Secondary to Cancer Therapy in Children Lymphoma||Other: medical chart review Other: questionnaire administration Procedure: management of therapy complications|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||530 participants|
|Official Title:||Health-Related Outcomes For Hodgkin's Disease Survivors|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||June 27, 2011|
Self report/Medical record review/ clinical eval
|Other: medical chart review Other: questionnaire administration Procedure: management of therapy complications|
- Risk for a specific adverse condition until the earliest of death, development of the adverse condition, loss to follow up, or completion of questionnaire [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091091
|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|