Study of the Physical and Emotional Needs of Parents Caring for Children Receiving Chemotherapy for Acute Lymphoblastic Leukemia
- Conditions
- Leukemia
- Interventions
- Other: questionnaire administration
- Registration Number
- NCT00056069
- Lead Sponsor
- Children's Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Observational questionnaire administration 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.
- Primary Outcome Measures
Name Time Method Event Free Survival Length of study
- Secondary Outcome Measures
Name Time Method Total score from the CMCC Length of study 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 Length of study
Trial Locations
- Locations (121)
Naval Medical Center - Portsmouth
🇺🇸Portsmouth, Virginia, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
🇺🇸Charleston, West Virginia, 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
Sacred Heart Children's Hospital
🇺🇸Pensacola, Florida, United States
Pediatric Specialty Clinic at Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Keesler Medical Center - Keesler Air Force Base
🇺🇸Keesler AFB, Mississippi, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute at University of Alberta
🇨🇦Edmonton, Alberta, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Baptist-South Miami Regional Cancer Program
🇺🇸Miami, Florida, 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
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
MBCCOP - South Texas Pediatrics
🇺🇸San Antonio, Texas, United States
Stanford Cancer Center at Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
University of South Alabama Cancer Research Institute
🇺🇸Mobile, Alabama, United States
Kaplan Cancer Center at St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
Walter Reed Army Medical Center
🇺🇸Silver Spring, Maryland, United States
UMASS Memorial Cancer Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Schneider Children's Hospital
🇺🇸New Hyde Park, New York, United States
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
🇺🇸Tulsa, Oklahoma, 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
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
St. Joseph's Children's Hospital of Tampa
🇺🇸Tampa, Florida, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
🇺🇸Portland, Oregon, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Broward General Medical Center Cancer Center
🇺🇸Fort Lauderdale, Florida, United States
Children's Hospital of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Joe DiMaggio Children's Hospital at Memorial
🇺🇸Hollywood, Florida, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
🇺🇸Atlanta, Georgia, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Advocate Hope Children's Hospital
🇺🇸Oak Lawn, Illinois, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Floating Hospital for Children
🇺🇸Boston, Massachusetts, 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
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Beth Israel Medical Center - Singer Division
🇺🇸New York, New York, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
🇺🇸Greenville, North Carolina, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
🇺🇸Houston, Texas, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Carilion Medical Center for Children at Roanoke Community Hospital
🇺🇸Roanoke, Virginia, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
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
Saint Jude Midwest Affiliate
🇺🇸Peoria, Illinois, United States
MBCCOP-Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
🇺🇸Santa Clara, California, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Center for Cancer Prevention and Care at Scott and White Clinic
🇺🇸Temple, Texas, United States
INOVA Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Yale Comprehensive Cancer Center at Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Nemours Children's Clinic - Orlando
🇺🇸Orlando, Florida, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, 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
Massey Cancer Center at Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States