Quality of Life in Children Treated for Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Center and Beckman Research Institute, City of Hope | Duarte | California | United States | 91010-3000 |
| 2 | CCOP - Bay Area Tumor Institute | Oakland | California | United States | 94609-3305 |
| 3 | CCOP - Colorado Cancer Research Program, Inc. | Denver | Colorado | United States | 80209-5031 |
| 4 | CCOP - Christiana Care Health Services | Wilmington | Delaware | United States | 19899 |
| 5 | CCOP - Iowa Oncology Research Association | Des Moines | Iowa | United States | 50309-1016 |
| 6 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0752 |
| 7 | CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | United States | 49503 |
| 8 | CCOP - Duluth | Duluth | Minnesota | United States | 55805 |
| 9 | Children's Hospitals and Clinics - Minneapolis | Minneapolis | Minnesota | United States | 55404 |
| 10 | Children's Hospitals and Clinics of Minnesota | Saint Paul | Minnesota | United States | 55102 |
| 11 | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
| 12 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
| 13 | CCOP - Merit Care Hospital | Fargo | North Dakota | United States | 58122 |
| 14 | CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania | United States | 17822-2001 |
| 15 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 16 | CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | United States | 57104 |
| 17 | CCOP - Marshfield Medical Research and Education Foundation | Marshfield | Wisconsin | United States | 54449 |
Sponsors and Collaborators
- Children's Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Smita Bhatia, MD, MPH, City of Hope Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AS972
- CCG-AS972
- CCG-S9702
- NCI-P00-0148
- CDR0000067920