Clinical Trials (PDQ®) - National Cancer Institute

Page Options

Clinical Trial Questions?

Get Help:

	Quick Links


	Help Using the NCI Clinical Trials Search Form Educational Materials About Clinical Trials About NCI's Cancer Clinical Trials Registry Dictionary of Cancer Terms NCI Drug Dictionary

Study of Parental Caregiving Demands of Children With Acute Lymphoblastic Leukemia Receiving Therapy on Different Infusion Schedules

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Educational/Counseling/Training Closed 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 Contact Information

Trial Lead Organizations

Children's Oncology Group

Diane Keegan Wells, RN, MSN, CPNP, Protocol chair
Ph: 410-328-2808; 800-888-8823

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

Registered in ClinicalTrials.gov		NCT00056069

Date Submitted to PDQ		2003-01-28

Information Last Verified		2005-11-02

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.