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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00056069
Registration number
NCT00056069
Ethics application status
Date submitted
6/03/2003
Date registered
7/03/2003
Date last updated
7/05/2015
Titles & IDs
Public title
Study of the Physical and Emotional Needs of Parents Caring for Children Receiving Chemotherapy for Acute Lymphoblastic Leukemia
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Scientific title
Differences in Parental Caregiving Demands in Childhood Acute Lymphoblastic Leukemia by Length of Infusion Therapy
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Secondary ID [1]
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COG-ACCL01P3
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Secondary ID [2]
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ACCL01P3
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - questionnaire administration
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.
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event Free Survival
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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Length of study
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Secondary outcome [2]
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Total score from the CMCC
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Assessment method [2]
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Timepoint [2]
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Length of study
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Eligibility
Key inclusion 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
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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2002
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2010
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Sample size
Target
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Accrual to date
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Final
172
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Children's Hospital at Westmead - Westmead
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Recruitment hospital [2]
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Royal Children's Hospital - Brisbane
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Recruitment hospital [3]
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Royal Children's Hospital - Parkville
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4029 - Brisbane
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment outside Australia
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United States of America
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Alabama
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Connecticut
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Florida
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Bern
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Geneva
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00056069
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Diane Keegan Wells, RN, MSN, CPNP
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Address
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University of Maryland Greenebaum Cancer Center
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00056069
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