NCT00091091

Long-Term Effects of Treatment in Patients Previously Treated for Childhood Hodgkin's Lymphoma

Health-Related Outcomes For Hodgkin's Disease Survivors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 530 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Long-term Effects Secondary to Cancer Therapy in Children
• Lymphoma

Interventions

Type	Name	Description
OTHER	medical chart review
OTHER	questionnaire administration
PROCEDURE	management of therapy complications

Timeline

• Start date: 2004-12-01
• Primary completion: 2011-06-27
• First posted: 2004-09-08
• Last updated: 2018-07-16

Locations

15 sites across 1 country: United States