Quality of Life in Children Treated for Cancer

NCT ID: NCT00005881

Last Updated: 2013-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

538 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-04-30

Study Completion Date

2006-09-30

Brief Summary

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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

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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

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Leukemia Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

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recurrent childhood acute lymphoblastic leukemia childhood Burkitt lymphoma stage I childhood lymphoblastic lymphoma stage II childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma unspecified childhood solid tumor, protocol specific childhood acute myeloid leukemia in remission stage II childhood Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma stage I childhood small noncleaved cell lymphoma stage I childhood large cell lymphoma stage II childhood small noncleaved cell lymphoma stage II childhood large cell lymphoma stage III childhood small noncleaved cell lymphoma stage III childhood large cell lymphoma stage IV childhood small noncleaved cell lymphoma stage IV childhood large cell lymphoma recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Quality of Life Forms

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

8 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Smita Bhatia, MD, MPH

Role: STUDY_CHAIR

City of Hope Comprehensive Cancer Center

Locations

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Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

CCOP - Colorado Cancer Research Program, Inc.

Denver, Colorado, United States

Site Status

CCOP - Christiana Care Health Services

Wilmington, Delaware, United States

Site Status

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

CCOP - Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, United States

Site Status

CCOP - Duluth

Duluth, Minnesota, United States

Site Status

Children's Hospitals and Clinics - Minneapolis

Minneapolis, Minnesota, United States

Site Status

Children's Hospitals and Clinics of Minnesota

Saint Paul, Minnesota, United States

Site Status

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

CCOP - Merit Care Hospital

Fargo, North Dakota, United States

Site Status

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, United States

Site Status

CCOP - Marshfield Medical Research and Education Foundation

Marshfield, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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CCG-AS972

Identifier Type: OTHER

Identifier Source: secondary_id

CCG-S9702

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-P00-0148

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000067920

Identifier Type: OTHER

Identifier Source: secondary_id

AS972

Identifier Type: -

Identifier Source: org_study_id