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Clinical Trials/NCT00005881
NCT00005881
Completed
Not Applicable

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

Children's Oncology Group17 sites in 1 country538 target enrollmentApril 2000

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leukemia
Sponsor
Children's Oncology Group
Enrollment
538
Locations
17
Primary Endpoint
Quality of life questionnaire
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2000
End Date
September 2006
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)
  • Test internal scale reliability(Length of study)

Study Sites (17)

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