Quality of Life in Children Treated for Cancer
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|ClinicalTrials.gov Identifier: NCT00005881|
Recruitment Status : Completed
First Posted : February 2, 2004
Last Update Posted : August 23, 2013
RATIONALE: Questionnaires that measure quality of life may improve the ability to plan treatment for children with cancer.
PURPOSE: This randomized clinical trial is studying the quality of life in children treated for cancer.
|Condition or disease||Intervention/treatment|
|Leukemia Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific||Other: Quality of Life Forms|
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.
|Study Type :||Observational|
|Actual Enrollment :||538 participants|
|Official Title:||Assessment of Health/Quality of Life in Survivors of Childhood Cancer|
|Study Start Date :||April 2000|
|Actual Primary Completion Date :||March 2003|
|Actual Study Completion Date :||September 2006|
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.
Other: 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.
- Quality of life questionnaire [ Time Frame: Length of study ]To complete the development of a self-reported, quality of life questionnaire (MM-QOL) for the pediatric oncology population.
- To see if this measure will discriminate between i) those undergoing treatment for cancer, ii) those who are survivors of cancer, and iii) a national sample of age- and sex-matched controls. [ Time Frame: Length of study ]To assess the validity of a quality of life questionnaire (MM-QOL) that is being developed for survivors of childhood cancer. To see if this measure will discriminate between i) those undergoing treatment for cancer, ii) those who are survivors of cancer, and iii) a national sample of age- and sex-matched controls (data has already been collected on the latter). To compare the responses to the new scale items with those from established scales (CHQ) that tap relevant QOL domains such as emotional, social, and physical functioning.
- Test internal scale reliability [ Time Frame: Length of study ]To assess the reliability of a quality of life questionnaire (MM-QOL) that is being developed for the survivors of childhood cancer. To test internal scale reliability (studies already being conducted). To assess test-retest reliability.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005881
|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|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0752|
|CCOP - Grand Rapids Clinical Oncology Program|
|Grand Rapids, Michigan, United States, 49503|
|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, MPH||City of Hope Comprehensive Cancer Center|