Introduction

This summary is intended to provide a general overview of the Children's Oncology Group (COG) study ALTE07C1. It will provide information about the children 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 study participation at www.childrensoncologygroup.org. Always discuss any questions that you may have with your healthcare team.

Study Number

ALTE07C1

Official Title

Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children with Cancer

Trial Opening Date

ALTE07C1 opened on September 15, 2008. There is no set number of people that will take part in this study. This study does not have a set end date. As of February 12, 2018, 809 patients are enrolled.

General Patient Eligibility

Patients are eligible to participate in this study if:

  • They are currently enrolled or plan to enroll on a COG treatment protocol that aims to examine neuropsychological, social, emotional and/or behavioral functioning.
  • The patient is able to both understand and speak English, French or Spanish.

Patients with a history of moderate or profound mental retardation (IQ ≤ 55) are not eligible for this study.

Please consult your doctor to determine whether your child may participate in this study.

General Background and Study Goal

Neuropsychological function is a measure of how a person learns, thinks or behaves. Certain cancers and treatments can cause negative effects to the central nervous system, including the brain, which affects the patient’s neuropsychological function. These problems can lead to trouble remembering, paying attention, planning ahead and keeping up with their classmates at school. This can greatly impact the quality of life of those suffering from these effects. It is important to understand the late effects that can occur as a result of childhood cancer and its various treatments. This information may help improve treatment planning for children with cancer in the future.

The overall goal of this study is to learn about the neuropsychological and behavioral functioning of children being treated for cancer. Another goal of this study is to find out if a standard set (called a battery) of neuropsychological and behavioral tests can be consistently completed at all of the COG hospitals and at three standard time points.

Summary of the Treatment

Patients on this study will be given a set of neuropsychological tests. These tests will be used to learn about the patient’s neuropsychological and behavioral functioning, for example, thinking, learning, and remembering. While the patient is taking these tests, the patient’s parent, or another person who knows the patient well, will fill in answers to a set of written questions. These questions will be used to learn more about the patient, for example, about his/her social skills, emotional well-being and behavior.

The patient will have three testing sessions, each lasting about one hour. These sessions will take place 9, 30 and 60 months after being diagnosed with cancer.

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 for your child to be in the study.

The study consent form has more details about possible risks and side effects of this study.

Contact Information

Your child's oncologist and nurses are the best sources for further information

Study Chair

Leanne Embry, PhD
Behavioral Science
University of Texas Health Science Center at San Antonio

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS

Initial development Name Date
Written by (protocol nurse) Jennifer Hudson, MS, RN, APRN, CPNP, CPHON July 8, 2012
Reviewed/approved by (PI) Leanne Embry, PhD
Ongoing review
Reviewed and updated by Elizabeth P. Bell, RN, BSN; Dee Ann Omatsu, APRN, PNP-BC, CPON April 25, 2017
February 12, 2018

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