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LeukemiaNCT00056069

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

A study testing questionnaire administration in people with Leukemia, run by Children's Oncology Group at 122 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Leukemia
What is being tested?
questionnaire administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
122 sitesin 6 countries
Study dates
Dec 2002to Mar 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

122 sites in 6 countries.

122 sites in 6 countries

United States107 sites

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus

    Atlanta, Georgia, 30342

  • MBCCOP-Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912-4000

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201-1595

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-7223

  • Pediatric Specialty Clinic at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Floating Hospital for Children

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114-2696

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05401-3498

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

    Charleston, West Virginia, 25302

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78466

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390-9063

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • INOVA Fairfax Hospital

    Falls Church, Virginia, 22042-3300

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0296

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-9070

  • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital

    Greenville, North Carolina, 27858-4354

  • Children's Hospital of Greenville Hospital System

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Joe DiMaggio Children's Hospital at Memorial

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital

    Houston, Texas, 77030-2399

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • East Tennessee State University Cancer Center at Johnson City Medical Center

    Johnson City, Tennessee, 37614-0622

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Keesler Medical Center - Keesler Air Force Base

    Keesler Air Force Base, Mississippi, 39534-2511

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236-5300

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 30101

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176-2197

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • University of South Alabama Cancer Research Institute

    Mobile, Alabama, 36604

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9300

  • Yale Comprehensive Cancer Center at Yale University School of Medicine

    New Haven, Connecticut, 06520-8064

  • Schneider Children's Hospital

    New Hyde Park, New York, 11040

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane Cancer Center at Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Children's Hospital of New Orleans

    New Orleans, Louisiana, 70118

  • Ochsner Cancer Institute at Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Beth Israel Medical Center - Singer Division

    New York, New York, 10128

  • Advocate Hope Children's Hospital

    Oak Lawn, Illinois, 60453

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Nemours Children's Clinic - Orlando

    Orlando, Florida, 32806

  • Stanford Cancer Center at Stanford University Medical Center

    Palo Alto, California, 94304-1812

  • Sacred Heart Children's Hospital

    Pensacola, Florida, 32504

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61637

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center & Children's Hospital

    Portland, Oregon, 97227

  • Naval Medical Center - Portsmouth

    Portsmouth, Virginia, 23708-5100

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Massey Cancer Center at Virginia Commonwealth University

    Richmond, Virginia, 23298-0121

  • Carilion Medical Center for Children at Roanoke Community Hospital

    Roanoke, Virginia, 24029

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Sutter Cancer Center

    Sacramento, California, 95816

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78207

  • MBCCOP - South Texas Pediatrics

    San Antonio, Texas, 78229-3900

  • Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego

    San Diego, California, 92120

  • Children's Hospital and Health Center - San Diego

    San Diego, California, 92123-4282

  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus

    Santa Clara, California, 95051

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074-9308

  • Walter Reed Army Medical Center

    Silver Spring, Maryland, 20910

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • Long Island Cancer Center at Stony Brook University Hospital

    Stony Brook, New York, 11794-8174

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-0001

  • St. Joseph's Children's Hospital of Tampa

    Tampa, Florida, 33677-4227

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Center for Cancer Prevention and Care at Scott and White Clinic

    Temple, Texas, 76508

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Kaplan Cancer Center at St. Mary's Medical Center

    West Palm Beach, Florida, 33407

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1081

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01655

Other trials in United States

Canada8 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T2T 5C7

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8S 4J9

  • Montreal Children's Hospital at McGill University Health Center

    Montreal, Quebec, H3H 1P3

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Centre de Recherche du Centre Hospitalier de l'Universite Laval

    Sainte-Foy, Quebec, GIV 4G2

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Australia3 sites

  • Royal Children's Hospital

    Brisbane, Queensland, 4029

  • Royal Children's Hospital

    Parkville, Victoria, 3052

  • Children's Hospital at Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

Switzerland2 sites

  • Swiss Pediatric Oncology Group Bern

    Bern, CH 3010

  • Swiss Pediatric Oncology Group Geneva

    Geneva, CH 1211

Other trials in Switzerland

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9700 RB

Other trials in Netherlands

Puerto Rico1 site

  • San Jorge Children's Hospital

    Santurce, 00912

Other trials in Puerto Rico

About this study

Official title: Differences in Parental Caregiving Demands in Childhood Acute Lymphoblastic Leukemia by Length of Infusion Therapy

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.

Read the 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.

Conditions
Leukemia
Being tested
questionnaire administration
Keywords
psychosocial effects of cancer and its treatment, childhood acute lymphoblastic leukemia
Medical subject headings
Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • questionnaire administrationOther

    Also called Ancillary studies

    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.

Study groups in NCT00056069
Study groupRoleWhat they receive
ObservationalExperimentalQuestionnaire 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.
Receives: Other: questionnaire administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free Survival

    Measured: Length of study

Secondary outcomes (2)

  1. 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

    Measured: Length of study

  2. Total score from the CMCC

    Measured: Length of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2003 (estimated)
  2. Study startDec 2002
  3. Primary completionJan 2010
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00056069
Sponsor's protocol ID
ACCL01P3
Other IDs
COG-ACCL01P3, CDR0000271934, NCI-2012-02522, U10CA095861
Status last verified
May 2015
First submitted
6 Mar 2003
Last updated
7 May 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing questionnaire administration in people with Leukemia, run by Children's Oncology Group at 122 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in United States, Canada, Australia, Switzerland, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival (time frame: Length of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00056069.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2015.

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