Clinical trial NCT00902213: Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia
Official title: Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia: A Nursing Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-15
Enrollment: 122
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone Mineral Density/Bone Mineral Content
timeFrame: Assessed at baseline and at completion of therapy
Secondary outcomes:
measure: Health- related quality of life
timeFrame: Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: AFLAC Cancer Center Children's Healthcare of Atlanta
state: Georgia
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Toronto
country: Canada
facility: Toronto Hospital for Sick Children
state: Ontario
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Cheryl L Cox, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ness KK, Kaste SC, Zhu L, Pui CH, Jeha S, Nathan PC, Inaba H, Wasilewski-Masker K, Shah D, Wells RJ, Karlage RE, Robison LL, Cox CL. Skeletal, neuromuscular and fitness impairments among children with newly diagnosed acute lymphoblastic leukemia. Leuk Lymphoma. 2015 Apr;56(4):1004-11. doi: 10.3109/10428194.2014.944519. Epub 2014 Aug 20.