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

Health-Related Outcomes For Hodgkin's Disease Survivors

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Long-term Effects Secondary to Cancer Therapy in Children
• Intervention / Treatment: Other: medical chart review; Other: questionnaire administration; Procedure: management of therapy complications

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.

• Study Type: Observational
• Enrollment (Actual): 530

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 95798
      • Lucile Packard Children's Hospital at Stanford University Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8028
      • Yale Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago Cancer Research Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center Cancer Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10032
      • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
    • Rochester, New York, United States, 14642
      • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Children's Hospital Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-9786
      • Children's Hospital of Philadelphia
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital Comprehensive Cancer Center
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital
    • Nashville, Tennessee, United States, 37232-6838
      • Vanderbilt-Ingram Cancer Center
  • Texas
    • Dallas, Texas, United States, 75390
      • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Washington
    • Seattle, Washington, United States, 98105
      • Children's Hospital and Regional Medical Center - Seattle
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54307-3508
      • St. Vincent Hospital Regional Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Treatment for primary Hodgkin disease at any one of the participating institutions 1987 - onward, or patients otherwise eligible and currently followed at one of the participating institutions.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patients; Self report/Medical record review/ clinical eval	Other: medical chart review; Other: questionnaire administration; Procedure: management of therapy complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk for a specific adverse condition until the earliest of death, development of the adverse condition, loss to follow up, or completion of questionnaire	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.	length of study

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Debra L. Friedman, MD, MS, Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): June 27, 2011
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: September 7, 2004
• First Submitted That Met QC Criteria: September 7, 2004
• First Posted (Estimate): September 8, 2004

Study Record Updates

• Last Update Posted (Actual): July 16, 2018
• Last Update Submitted That Met QC Criteria: July 13, 2018
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: long-term effects secondary to cancer therapy in children; stage IV childhood Hodgkin lymphoma; stage III childhood Hodgkin lymphoma; stage I childhood Hodgkin lymphoma; stage II childhood Hodgkin lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: ALTE04N1; COG-ALTE04N1 (Other Identifier: Children's Oncology Group); CDR0000383244 (Other Identifier: Clinical Trials.gov); NCI-2009-00381 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No