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

Children's Oncology Group

Status: Completed

Conditions: Lymphoma; Long-term Effects Secondary to Cancer Therapy in Children

Treatments: Other: medical chart review; Other: questionnaire administration; Procedure: management of therapy complications

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00091091

NCI-2009-00381 (Registry Identifier)

ALTE04N1

COG-ALTE04N1 (Other Identifier)

CDR0000383244 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 530 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

530 participants in 1 patient group

All patients

Description:

Self report/Medical record review/ clinical eval

Treatment:

Other: medical chart review

Procedure: management of therapy complications

Other: questionnaire administration