Acute Lymphoblastic Leukemia
Conditions
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.
Interventions
BEHAVIORALPhysical 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.
BEHAVIORALSupport
Visits with an Advanced Practice Nurse to support sustained motivation.
Sponsors
National Cancer Institute (NCI)
St. Jude Children's Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone Mineral Density/Bone Mineral Content | Assessed at baseline and at completion of therapy |
Secondary
| Measure | Time frame |
|---|---|
| Health- related quality of life | Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy |
Countries
Canada, United States
Outcome results
None listed