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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Differences in Parental Caregiving Demands in Childhood Acute Lymphoblastic Leukemia by Length of Infusion Therapy
Secondary ID [1] 0 0
COG-ACCL01P3
Secondary ID [2] 0 0
ACCL01P3
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Free Survival
Timepoint [1] 0 0
Length of study
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Length of study
Secondary outcome [2] 0 0
Total score from the CMCC
Timepoint [2] 0 0
Length of study

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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2010
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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California
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Connecticut
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Florida
Country [7] 0 0
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Georgia
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United States of America
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Hawaii
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United States of America
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Illinois
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United States of America
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Kansas
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United States of America
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Louisiana
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United States of America
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Maine
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Maryland
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Massachusetts
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United States of America
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Michigan
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Mississippi
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Missouri
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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United States of America
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Vermont
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Virginia
Country [32] 0 0
United States of America
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Washington
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United States of America
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West Virginia
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United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Canada
State/province [35] 0 0
Alberta
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Netherlands
State/province [38] 0 0
Groningen
Country [39] 0 0
Puerto Rico
State/province [39] 0 0
Santurce
Country [40] 0 0
Switzerland
State/province [40] 0 0
Bern
Country [41] 0 0
Switzerland
State/province [41] 0 0
Geneva

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00056069
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Diane Keegan Wells, RN, MSN, CPNP
Address 0 0
University of Maryland Greenebaum Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00056069