Study of the Physical and Emotional Needs of Parents Caring for Children Receiving Chemotherapy for Acute Lymphoblastic Leukemia
NCT ID: NCT00056069
Last Updated: 2015-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
172 participants
INTERVENTIONAL
2002-12-31
2010-03-31
Brief Summary
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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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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Diane Keegan Wells, RN, MSN, CPNP
Role: STUDY_CHAIR
University of Maryland Greenebaum Cancer Center
Locations
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Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
University of South Alabama Cancer Research Institute
Mobile, Alabama, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Stanford Cancer Center at Stanford University Medical Center
Palo Alto, California, United States
Sutter Cancer Center
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
San Diego, California, United States
Children's Hospital and Health Center - San Diego
San Diego, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, United States
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Joe DiMaggio Children's Hospital at Memorial
Hollywood, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Nemours Children's Clinic - Orlando
Orlando, Florida, United States
Sacred Heart Children's Hospital
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
Atlanta, Georgia, United States
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Rush University Medical Center
Chicago, Illinois, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Pediatric Specialty Clinic at Eastern Maine Medical Center
Bangor, Maine, United States
Maine Children's Cancer Program
Scarborough, Maine, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Walter Reed Army Medical Center
Silver Spring, Maryland, United States
Floating Hospital for Children
Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Keesler Medical Center - Keesler Air Force Base
Keesler Air Force Base, Mississippi, United States
University of Missouri - Columbia
Columbia, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Beth Israel Medical Center - Singer Division
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States
East Tennessee State University Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
MBCCOP - South Texas Pediatrics
San Antonio, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Center for Cancer Prevention and Care at Scott and White Clinic
Temple, Texas, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
INOVA Fairfax Hospital
Falls Church, Virginia, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States
Carilion Medical Center for Children at Roanoke Community Hospital
Roanoke, Virginia, United States
Madigan Army Medical Center
Tacoma, Washington, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Royal Children's Hospital
Brisbane, Queensland, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Alberta Children's Hospital
Calgary, Alberta, Canada
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Centre de Recherche du Centre Hospitalier de l'Universite Laval
Sainte-Foy, Quebec, Canada
University Medical Center Groningen
Groningen, , Netherlands
San Jorge Children's Hospital
Santurce, , Puerto Rico
Swiss Pediatric Oncology Group Bern
Bern, , Switzerland
Swiss Pediatric Oncology Group Geneva
Geneva, , Switzerland
Countries
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Other Identifiers
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COG-ACCL01P3
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000271934
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-02522
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACCL01P3
Identifier Type: -
Identifier Source: org_study_id
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