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

Tracking Information
First Submitted Date ICMJE	March 6, 2003
First Posted Date ICMJE	March 7, 2003
Last Update Posted Date	May 7, 2015
Study Start Date ICMJE	December 2002
Actual Primary Completion Date	January 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 30, 2013)	Event Free Survival [ Time Frame: Length of study ]
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00056069 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 30, 2013)	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 [ Time Frame: Length of study ]; Total score from the CMCC [ Time Frame: Length of study ]
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study of the Physical and Emotional Needs of Parents Caring for Children Receiving Chemotherapy for Acute Lymphoblastic Leukemia
Official Title ICMJE	Differences in Parental Caregiving Demands in Childhood Acute Lymphoblastic Leukemia by Length of Infusion Therapy
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Leukemia
Intervention ICMJE	Other: questionnaire 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.; Other Name: Ancillary studies
Study Arms	Experimental: Observational; Questionnaire 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.; Intervention: Other: questionnaire administration
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 30, 2013)	172
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	March 2010
Actual Primary Completion Date	January 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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 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 PRIOR CONCURRENT THERAPY: Biologic therapy; Not specified Chemotherapy; Not specified Endocrine therapy; Not specified Radiotherapy; Not specified Surgery; Not specified
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Australia, Canada, Netherlands, Puerto Rico, Switzerland, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00056069
Other Study ID Numbers ICMJE	ACCL01P3; COG-ACCL01P3 ( Other Identifier: Children's Oncology Group ); CDR0000271934 ( Other Identifier: NCI ); NCI-2012-02522 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); U10CA095861 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Children's Oncology Group
Study Sponsor ICMJE	Children's Oncology Group
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Study Chair: Diane Keegan Wells, RN, MSN, CPNP University of Maryland Greenebaum Cancer Center
PRS Account	Children's Oncology Group
Verification Date	May 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP