Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- Behavioral: Physical TherapyBehavioral: Support
- Registration Number
- NCT00902213
- Lead Sponsor
- St. Jude Children's Research Hospital
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
- An immunophenotypic diagnosis of non-B cell ALL
- Age 4 years through <19 years at diagnosis
- 2-8 days on or per front line ALL treatment protocol
- One parent or legal guardian (≥ 18 years) of the study subject who speaks and understands the English Language
- Participant speaks and understands the English language
- Written informed consent and child assent
- Age < 4 years or ≥19 years at diagnosis
- A diagnosis of cerebral palsy or down syndrome
- Second malignancy, chromosome breakage syndrome, or severe congenital immunodeficiency
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent
- Females who are pregnant.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Physical Therapy Support - Physical Therapy Physical Therapy -
- Primary Outcome Measures
Name Time Method Bone Mineral Density/Bone Mineral Content Assessed at baseline and at completion of therapy
- Secondary Outcome Measures
Name Time Method Health- related quality of life Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy
Trial Locations
- Locations (4)
AFLAC Cancer Center Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
MD Anderson
🇺🇸Houston, Texas, United States
Toronto Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada