Introduction

This lay summary is intended to provide a general overview of the Children’s Oncology Group (COG) study ALTE1631. It will provide information about the children and adolescents who are eligible for this study and basic information regarding the specifics of the study. The informed consent and protocol contain the full details of the study. Those documents are available to you from your oncologist.

It is important to understand that participating in a long-term follow-up study is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the healthcare team in any way. You can find additional information about participation in non-therapeutic studies at www.childrensoncologygroup.org. Always discuss any questions that you may have with your health care team.

Study Number

ALTE1631

Brief Title

COG ALTE1631 – COG ALL Stars

Official Title

A Randomized Web-based Physical Activity Intervention among Children and Adolescents with Acute Lymphoblastic Leukemia

Trial Opening Date

Opened August 14, 2017

General Patient Eligibility

• Patients diagnosed with acute lymphoblastic leukemia (ALL) and completed treatment within the last 3 months
• Patients must be between the ages of 8 and 15 years old
• Patients must have access to a computer or smart phone with Android 4.3 or later or iOS 7.1 or later to use the website
• At time of consent, patient or parent/guardian report less than 420 minutes (7 hours) of moderate to vigorous physical activity over the last week

General Background and Study Goal

Children and adolescents that have received treatment for ALL are at risk for gaining weight and having lower activity levels, feeling tired, and having problems with their bones, muscles, and overall health. Researchers are investigating whether an interactive website encouraging more physical activity can improve fitness, quality of life, and physical health in children and adolescents who have completed therapy for ALL.

Summary of the Treatment

Patients that decide to participate in this study will:

• Be given a physical activity monitor called a Sqord, access to a website (Sqord.com) where they can see their own activity and earn rewards
• Be asked to wear the Sqord device for 6 months and attend 4 clinic visits over 18 months. At each clinic visit, the patient’s weight, height, and waist will be measured. Blood pressure will be checked and the patient will be asked to complete a walking test. Blood will be collected to run special tests.

Risks and Side Effects

All risks and side effects will be explained by your study team during the consent process. They can answer any questions that you may have about giving permission to be in the study. The study consent form has more details about possible risks and side effects of this study.

Contact Information

Your oncologist is the best source for further information. Physicians with eligible patients should refer questions to the principal investigator:

Principal Investigator
Kirsten K. Ness, PT, PhD, FAPTA
St. Jude’s Children’s Research Hospital

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS