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

Lymphoma Clinical Trial

Official title:

Health-Related Outcomes For Hodgkin's Disease Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091091
• Other study ID #: ALTE04N1
• Secondary ID: COG-ALTE04N1CDR0
• Status: Completed
• Start date: December 2004

Study information

• Verified date: February 2017
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. primary completion date: June 27, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• medical chart review

• questionnaire administration

Procedure:
• management of therapy complications

Locations

Country	Name	City	State
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Hackensack University Medical Center Cancer Center	Hackensack	New Jersey
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Yale Cancer Center	New Haven	Connecticut
United States	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Lucile Packard Children's Hospital at Stanford University Medical Center	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Rhode Island Hospital Comprehensive Cancer Center	Providence	Rhode Island
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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