Quality of Life in Children Treated for Cancer

August 22, 2013 updated by: Children's Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

538

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • Cancer Center and Beckman Research Institute, City of Hope
      • Oakland, California, United States, 94609-3305
        • CCOP - Bay Area Tumor Institute
    • Colorado
      • Denver, Colorado, United States, 80209-5031
        • CCOP - Colorado Cancer Research Program, Inc.
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • CCOP - Christiana Care Health Services
    • Iowa
      • Des Moines, Iowa, United States, 50309-1016
        • CCOP - Iowa Oncology Research Association
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0752
        • University of Michigan Comprehensive Cancer Center
      • Grand Rapids, Michigan, United States, 49503
        • CCOP - Grand Rapids Clinical Oncology Program
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals and Clinics - Minneapolis
      • Saint Paul, Minnesota, United States, 55102
        • Children's Hospitals and Clinics of Minnesota
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • CCOP - Merit Care Hospital
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • CCOP - Sioux Community Cancer Consortium
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • CCOP - Marshfield Medical Research and Education Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Previous treatment for cancer or currently undergoing treatment for cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Length of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Length of study
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.
Length of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Smita Bhatia, MD, MPH, City of Hope Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

January 30, 2004

First Posted (Estimate)

February 2, 2004

Study Record Updates

Last Update Posted (Estimate)

August 23, 2013

Last Update Submitted That Met QC Criteria

August 22, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS972
  • CCG-AS972 (Other Identifier: Children's Cancer Group)
  • CCG-S9702 (Other Identifier: Children's Cancer Group)
  • NCI-P00-0148 (Other Identifier: NCI Trial Identifier)
  • CDR0000067920 (Other Identifier: Clinical Trials.gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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