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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia: A Nursing Trial

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Behavioral: Physical Therapy
* Behavioral: Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Minimal movement<br>Minimal movement group with usual care non-intervention. | |
| Active Comparator: Physical Therapy<br> | Behavioral: Physical Therapy<br>* 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.<br>* Other names: Physical Activity to Modify Sequelae and in Childhood ALL.;Behavioral: Support<br>* Visits with an Advanced Practice Nurse to support sustained motivation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density/Bone Mineral Content |  | Assessed at baseline and at completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health- related quality of life |  | Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy |