Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information
Study of the Physical and Emotional Needs of Parents Caring for Children Receiving Chemotherapy for Acute Lymphoblastic Leukemia
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Educational/Counseling/Training | Completed | Not specified | NCI | COG-ACCL01P3 NCT00056069, ACCL01P3 |
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.
Entry Criteria
Disease Characteristics:
- Parent or legal guardian who is the primary caregiver of a patient enrolled on COG-P9904 or COG-P9905 protocol
- Patient has not yet received week 13 of therapy
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Patient Characteristics:
Age
- Not specified
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Able to understand English
Expected Enrollment
A total of 164 participants will be accrued for this study within 0.8 years.
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.
Trial Lead Organizations
Children's Oncology Group
 | | | |
| Diane Keegan Wells, RN, MSN, CPNP, Protocol chair | |
| |
| |||
Related Information
PDQ® clinical trial COG-P9905
PDQ® clinical trial COG-P9904
| Registry Information | ||
| ||
| Official Title | Differences in Parental Caregiving Demands in Childhood Acute Lymphoblastic Leukemia by Length of Infusion Therapy | |
| ||
| Trial Start Date | 2002-12-23 | |
| ||
| Trial Completion Date | 2010-01-22 | |
| ||
| Registered in ClinicalTrials.gov | NCT00056069 | |
| ||
| Date Submitted to PDQ | 2003-01-28 | |
| ||
| Information Last Verified | 2010-11-12 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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