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

Health-Related Outcomes For Hodgkin's Disease Survivors

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00091091
Enrollment
530
Registered
2004-09-08
Start date
2004-12-31
Completion date
Unknown
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

OTHERmedical chart review
OTHERquestionnaire administration
PROCEDUREmanagement of therapy complications

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Risk for a specific adverse condition until the earliest of death, development of the adverse condition, loss to follow up, or completion of questionnairelength of studyThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026