Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
538 participants
OBSERVATIONAL
2000-04-30
2006-09-30
Brief Summary
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PURPOSE: This randomized clinical trial is studying the quality of life in children treated for cancer.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CROSS_SECTIONAL
Study Groups
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Quality of life forms
Completion of the development of an instrument \[Minneapolis-Manchester Quality of Life (MM-QOL)\] that measures HRQOL in the survivors of childhood cancer in a standardized, valid way and to assess the feasibility of incorporating this endpoint in a variety of clinical trials.
Quality of Life Forms
Completion of the instrument \[Minneapolis-Manchester Quality of Life (MM-QOL)\] that measures HRQOL in the survivors of childhood cancer in a standardized, valid way and to assess the feasibility of incorporating this endpoint in a variety of clinical trials.
Interventions
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Quality of Life Forms
Completion of the instrument \[Minneapolis-Manchester Quality of Life (MM-QOL)\] that measures HRQOL in the survivors of childhood cancer in a standardized, valid way and to assess the feasibility of incorporating this endpoint in a variety of clinical trials.
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 8 to 20 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: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
8 Years
20 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Smita Bhatia, MD, MPH
Role: STUDY_CHAIR
City of Hope Comprehensive Cancer Center
Locations
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Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Children's Hospitals and Clinics - Minneapolis
Minneapolis, Minnesota, United States
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States
Countries
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Other Identifiers
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CCG-AS972
Identifier Type: OTHER
Identifier Source: secondary_id
CCG-S9702
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-P00-0148
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000067920
Identifier Type: OTHER
Identifier Source: secondary_id
AS972
Identifier Type: -
Identifier Source: org_study_id