RATIONALE: Questionnaires that measure quality of life may improve the ability to plan treatment for children with cancer. PURPOSE: Randomized clinical trial to study quality of life in children treated for cancer.

Condition	Treatment or Intervention
Leukemia Lymphoma	Procedure: supportive care  Behavior: supportive care/therapy  Procedure: quality-of-life assessment

Further Study Details: 

OBJECTIVES: I. Assess the validity and reliability of a quality of life questionnaire (MM-QOL) that is being developed for patients with previously or currently treated childhood cancers.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (8-12 vs 13-20) and treatment (current vs previous). Patients are randomized to one of two arms of the study. Arm I (Reliability): Patients will complete the same questionnaire two weeks apart. (age 13-20 stratum closed as of 7/14/00) Arm II (Validity): Patients will complete a study questionnaire plus a Child Health Questionnaire. Patients between ages 8-12 are interviewed and patients between ages 13-20 complete a written questionnaire.

PROJECTED ACCRUAL: A total of 716 patients (416 for arm I (208 for 8-12 age group and 208 for 13-20 age group) and 300 for arm II (150 for 8-12 age group and 150 for 13-20 age group)) will be accrued for this study.

Ages Eligible for Study:  8 Years   -   20 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Prior or current diagnosis of any pediatric cancer; Current chemoradiotherapy (at least 2 months since start of therapy) OR At least 1 year since prior treatment and in remission

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: See Disease Characteristics
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics
• Surgery: Not specified

--Patient Characteristics--

• Age: 8 to 20
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified

California
      Cancer Center and Beckman Research Institute, City of Hope, Duarte,  California,  91010-3000,  United States
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States
Colorado
      CCOP - Colorado Cancer Research Program, Inc., Denver,  Colorado,  80209-5031,  United States
Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States
Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
Michigan
      CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids,  Michigan,  49503,  United States
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0752,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      Children's Hospitals and Clinics - Minneapolis, Minneapolis,  Minnesota,  55404,  United States
      Children's Hospitals and Clinics of Minnesota, Saint Paul,  Minnesota,  55102,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States
Wisconsin
      CCOP - Marshfield Medical Research and Education Foundation, Marshfield,  Wisconsin,  54449,  United States

Study chairs or principal investigators

Smita Bhatia,  Study Chair,  Children's Cancer Group   

Study ID Numbers:  CDR0000067920; CCG-AS972; NCI-P00-0148; CCG-S9702
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005881
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08