Quality of Life in Children Treated for Cancer
- Conditions
- LeukemiaLymphomaUnspecified Childhood Solid Tumor, Protocol Specific
- Interventions
- Other: Quality of Life Forms
- Registration Number
- NCT00005881
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 538
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Quality of life forms 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.
- Primary Outcome Measures
Name Time Method Quality of life questionnaire Length of study To complete the development of a self-reported, quality of life questionnaire (MM-QOL) for the pediatric oncology population.
- Secondary Outcome Measures
Name Time Method 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. 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 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.
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Trial Locations
- Locations (17)
Children's Hospitals and Clinics of Minnesota
🇺🇸Saint Paul, Minnesota, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Children's Hospitals and Clinics - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, 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