Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Newly Diagnosed Acute Lymphoblastic Leukemia in First Remission

PRIMARY OBJECTIVES:

I. To evaluate the effect of an interactive web-based physical activity intervention on
fitness among children and adolescents following treatment for acute lymphoblastic leukemia
(ALL).

SECONDARY OBJECTIVES:

I. To evaluate the effect of an interactive web-based physical activity intervention on
markers of cardiometabolic health among children and adolescents following treatment for ALL.

II. To evaluate the effect of an interactive web-based physical activity intervention on
physical activity, quality of life, fatigue, and school attendance among children and
adolescents following treatment for ALL.

III. To determine if the effect of an interactive web-based physical activity intervention on
markers of cardiometabolic health is mediated by changes in fitness among children and
adolescents following treatment for ALL.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive educational handouts about physical activity and are encouraged to
increase physical activity to at least 420 minutes per week. Patients wear Sqord activity
monitor daily and upload data at least once a week to the Sqord website. Patients also access
the limited version of Sqord website to get basic information related to their physical
activity for 6 months.

ARM II: Patients receive educational handouts about physical activity and are encouraged to
increase physical activity to at least 420 minutes per week. Patients wear Sqord activity
monitor daily and upload data at least once a week to the Sqord website. Patients also access
the full version of the interactive-reward based Sqord website to see their activity, earn
activity points, see other Sqord player's activity, and interact with other Sqord members for
6 months.

After completion of study, patients are followed up at 24 and 48 weeks.

Inclusion Criteria:

- Patient must be a newly diagnosed ALL, in first remission

- Patient must have completed curative chemotherapy within past 90 days at a Childrens
Oncology Group (COG) institution

- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1, or 2; use Lansky for patients =< 16 years of age

- At the time of consent, patient or parent/guardian reports less than 420 minutes of
moderate to vigorous physical activity over the last week

- Patient must have access to a smart phone with Android 4.3 or later or iOS 7.1 or
later or computer (laptop/desktop) with a connection to the internet to create an
account and be able to sync the Sqord device (accelerometer)

- Patient and at least one parent/guardian are able to read and write English; at least
1 parent/guardian must be able to read and write English in order to assist the
patient with using their Sqord account

Exclusion Criteria:

- Patients with previous hematopoietic stem cell transplant (HSCT)

- Patients with significant concurrent disease, illness, psychiatric disorder or social
issue that would compromise patient safety or compliance with protocol therapy, or
interfere with consent, study participation, follow up, or interpretation of study
results

- Female patients who are pregnant are not eligible; women of childbearing potential
require a negative pregnancy test

- Female patient who is postmenarcheal has agreed to use an effective contraceptive
method (including abstinence) for the duration of study participation