Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia
Status: | Completed |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 4 - 18 |
Updated: | 4/21/2016 |
Start Date: | November 2009 |
End Date: | May 2015 |
Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia: A Nursing Trial
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).
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).
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.
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.
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.
We found this trial at
4
sites
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