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| Sponsors and Collaborators: |
Children's Cancer Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005881 |
Purpose
RATIONALE: Questionnaires that measure quality of life may improve the ability to plan treatment for children with cancer.
PURPOSE: This randomized clinical trialis studying the quality of life in children treated for cancer.
| Condition | Intervention |
|---|---|
|
Cancer-Related Problem/Condition Leukemia Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific |
Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Randomized |
| Official Title: | Assessment of Health/Quality of Life in Survivors of Childhood Cancer |
| Study Start Date: | April 2000 |
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.
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.
Eligibility| Ages Eligible for Study: | 8 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
Contacts and Locations| United States, California | |
| Cancer Center and Beckman Research Institute, City of Hope | |
| Duarte, California, United States, 91010-3000 | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| United States, Colorado | |
| CCOP - Colorado Cancer Research Program, Inc. | |
| Denver, Colorado, United States, 80209-5031 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Wilmington, Delaware, United States, 19899 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| United States, Michigan | |
| CCOP - Grand Rapids Clinical Oncology Program | |
| Grand Rapids, Michigan, United States, 49503 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0752 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| Children's Hospitals and Clinics - Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| Children's Hospitals and Clinics of Minnesota | |
| Saint Paul, Minnesota, United States, 55102 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, North Dakota | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Pennsylvania | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Wisconsin | |
| CCOP - Marshfield Medical Research and Education Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Study Chair: | Smita Bhatia, MD | Beckman Research Institute |
More Information
| Study ID Numbers: | CDR0000067920, CCG-AS972, CCG-S9702, NCI-P00-0148 |
| Study First Received: | June 2, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005881 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent childhood acute lymphoblastic leukemia Burkitt lymphoma stage I childhood lymphoblastic lymphoma stage II childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma unspecified childhood solid tumor, protocol specific childhood acute myeloid leukemia in remission stage II childhood Hodgkin lymphoma stage I childhood Hodgkin lymphoma |
stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma quality of life stage I childhood small noncleaved cell lymphoma stage I childhood large cell lymphoma stage II childhood small noncleaved cell lymphoma stage II childhood large cell lymphoma stage III childhood small noncleaved cell lymphoma stage III childhood large cell lymphoma stage IV childhood small noncleaved cell lymphoma stage IV childhood large cell lymphoma recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma |
|
Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Hodgkin Lymphoma, Childhood Quality of Life Leukemia, Myeloid, Acute Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Leukemia Acute Myelocytic Leukemia Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-cell Hodgkin Disease Lymphoma |
Acute Lymphoblastic Leukemia Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hodgkin's Disease Leukemia, Myeloid Small Non-cleaved Cell Lymphoma Recurrence Acute Myeloid Leukemia, Childhood Lymphatic Diseases Burkitt's Lymphoma Burkitt Lymphoma Lymphoproliferative Disorders |
|
Lymphatic Diseases Leukemia Neoplasms Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Lymphoproliferative Disorders Lymphoma |
