NCT00005881

Quality of Life in Children Treated for Cancer

Assessment of Health/Quality of Life in Survivors of Childhood Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 538 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 8 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia
• Lymphoma
• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2000-04-01
• Primary completion: 2003-03-01
• Completion: 2006-09-01
• First posted: 2004-02-02
• Last updated: 2013-08-23

Locations

17 sites across 1 country: United States