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Clinical Trials/NCT00056069
NCT00056069
Completed
Not Applicable

Differences in Parental Caregiving Demands in Childhood Acute Lymphoblastic Leukemia by Length of Infusion Therapy

Children's Oncology Group121 sites in 1 country172 target enrollmentDecember 2002
ConditionsLeukemia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leukemia
Sponsor
Children's Oncology Group
Enrollment
172
Locations
121
Primary Endpoint
Event Free Survival
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2002
End Date
March 2010
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Event Free Survival

Time Frame: Length of study

Secondary Outcomes

  • Total score from the CMCC(Length 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 infusion(Length of study)

Study Sites (121)

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