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PAQOL: Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia

Sponsor
St. Jude Children's Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00902213
Collaborator
National Cancer Institute (NCI) (NIH)
122
Enrollment
4
Locations
2
Arms
65.9
Duration (Months)
30.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This will be the first multidisciplinary, randomized, longitudinal trial of a tailored, parent- and child-focused physical activity program for children (ages 4- <19 years) with newly diagnosed ALL. It will test the ability of the intervention to prevent or diminish early physical function limitations and improve health-related quality of life (HRQL). The intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) HRQL. This multi-site trial will test the intervention in 76 evaluable children with ALL (38 receiving the intervention and 38 receiving a placebo "minimal movement" standard care strategy).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Physical Therapy
  • Behavioral: Support
 N/A

Detailed Description

An advanced practice nurse (APN) will meet twice weekly with the patient and family for the first 4 weeks of the intervention to initiate the motivation-based dialogue and therapeutic interaction; this will be followed by once weekly visits during weeks 5-8 of the intervention; and monthly visits during weeks 9-through end of therapy. The physical therapist (PT) will meet at least once weekly with the patient and family during weeks 1-4 to initiate the prescriptive tailored exercise program; subsequent visits to reinforce and modify the program will occur at least once every other week during weeks 5-8, and at least once monthly during weeks 9-135 of the intervention. The PT will visit at least once weekly during weeks 1-4, at least once every other week during weeks 5-8, and at least once monthly during weeks 9-135. During weeks 9-135 of the intervention, the APN will call between the monthly in person-visits, if needed to those randomized to the MAP group to assure fidelity to the intervention and to provide booster support to the intervention where needed.

Study Design

Study Type:
Interventional
Actual Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia: A Nursing Trial
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Minimal movement

Minimal movement group with usual care non-intervention.
Active Comparator: Physical Therapy

Behavioral: Physical Therapy
Each patient in this group will have physical therapy performed. The intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) HRQL.
Other Names:
  • Physical Activity to Modify Sequelae and in Childhood ALL.

    • Behavioral: Support
    Visits with an Advanced Practice Nurse to support sustained motivation.

    Outcome Measures

    Primary Outcome Measures

    1. Bone Mineral Density/Bone Mineral Content [Assessed at baseline and at completion of therapy]

    Secondary Outcome Measures

    1. Health- related quality of life [Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. An immunophenotypic diagnosis of non-B cell ALL

    2. Age 4 years through <19 years at diagnosis

    3. 2-8 days on or per front line ALL treatment protocol

    4. One parent or legal guardian (≥ 18 years) of the study subject who speaks and understands the English Language

    5. Participant speaks and understands the English language

    6. Written informed consent and child assent

    Exclusion Criteria:

    1. Age < 4 years or ≥19 years at diagnosis

    2. A diagnosis of cerebral palsy or down syndrome

    3. Second malignancy, chromosome breakage syndrome, or severe congenital immunodeficiency

    4. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent

    5. Females who are pregnant.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AFLAC Cancer Center Children's Healthcare of Atlanta Atlanta Georgia United States 30342
    2 St. Jude Children's Research Hospital Memphis Tennessee United States 38105
    3 MD Anderson Houston Texas United States 77030
    4 Toronto Hospital for Sick Children Toronto Ontario Canada M5G1X8

    Sponsors and Collaborators

    • St. Jude Children's Research Hospital
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Cheryl L Cox, RN, PhD, St. Jude Children's Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    St. Jude Children's Research Hospital
    ClinicalTrials.gov Identifier:
    NCT00902213
    Other Study ID Numbers:
    • PAQOL
    • R01CA129384
    • NCI-2012-00017
    First Posted:
    May 15, 2009
    Last Update Posted:
    Nov 17, 2015
    Last Verified:
    Nov 1, 2015
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid

    Study Results

    No Results Posted as of Nov 17, 2015