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Study of the Physical and Emotional Needs of Parents Caring for Children Receiving Chemotherapy for Acute Lymphoblastic Leukemia

Not Applicable
Completed
Conditions
Leukemia
Interventions
Other: questionnaire administration
Registration Number
NCT00056069
Lead Sponsor
Children's Oncology Group
Brief Summary

RATIONALE: Studying the physical and emotional needs of parents who are caring for children receiving chemotherapy for cancer may help doctors plan effective treatments for the patient that allow for improved quality of life of the patient's family.

PURPOSE: This clinical trial is studying the different physical and emotional needs of parents whose children are undergoing chemotherapy for acute lymphoblastic leukemia either in an outpatient clinic or in the hospital.

Detailed Description

OBJECTIVES:

* Compare the caregiving demands reported by parents of children with acute lymphoblastic leukemia receiving methotrexate on 2 different infusion schedules (inpatient care vs outpatient care).

* Compare the change in caregiving demands on these parents over time, in terms of physical and emotional care, the need to make family arrangements, the need to communicate about the child's care, the need to gather information about the child's health status, and the effect on family well-being.

OUTLINE: Participants complete questionnaires regarding caregiver demands and family information over 25-30 minutes within 3-4 months of the initiation of the child's treatment and at the completion of the first year of the child's treatment.

PROJECTED ACCRUAL: A total of 164 participants will be accrued for this study within 0.8 years.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
172
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Observationalquestionnaire administrationQuestionnaire Administration: Participants complete questionnaires regarding caregiver demands and family information over 25-30 minutes within 3-4 months of the initiation of the child's treatment and at the completion of the first year of the child's treatment.
Primary Outcome Measures
NameTimeMethod
Event Free SurvivalLength of study
Secondary Outcome Measures
NameTimeMethod
Total score from the CMCCLength of study
Determine whether caregivers whose child is randomized to receive the 24-hour methotrexate infusion will report lower caregiving demand than will caregivers whose child is randomized to receive the 4-hour infusionLength of study

Trial Locations

Locations (121)

Comprehensive Cancer Center at University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

University of South Alabama Cancer Research Institute

🇺🇸

Mobile, Alabama, United States

Arizona Cancer Center at University of Arizona Health Sciences Center

🇺🇸

Tucson, Arizona, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

Rebecca and John Moores UCSD Cancer Center

🇺🇸

La Jolla, California, United States

Stanford Cancer Center at Stanford University Medical Center

🇺🇸

Palo Alto, California, United States

Sutter Cancer Center

🇺🇸

Sacramento, California, United States

University of California Davis Cancer Center

🇺🇸

Sacramento, California, United States

Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego

🇺🇸

San Diego, California, United States

Children's Hospital and Health Center - San Diego

🇺🇸

San Diego, California, United States

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Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
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