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

Not Applicable

Completed

• Conditions: Acute Lymphoblastic Leukemia

• 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.

Study Timeline

• Study First Submitted: 2009-05-13
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Study Start: 2009-11
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

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