Trial Information

A Pilot Study of the Effectiveness of Cognitive Training in Preventing Attention Deficits Among Children in Treatment for Cancer

The Cognitive Training Program (CTP) is made up of many elements. It includes procedures
that are designed to build five types of attention skills, as well as motivational
activities that exercise your child's attention processes. The CTP includes instructions on
how to improve the way your child's mind approaches a task, how he/she performs different
tasks, and what he/she does after finishing tasks. The CTP also includes the use of
therapy to improve and maintain motivation, self-esteem, and self-confidence, as well as to
help your child stay motivated and keep from getting distracted.

Before your child can take part in this study, he/she will have what is called a "screening
test of intelligence." This test will help the doctor decide if your child is eligible to
take part in the study. In order for a child to participate in the study, he or she has to
achieve a score > 70 on the screening test (at least within the borderline range of
intelligence), because this level of intelligence is necessary for a child to understand the
CPT educational materials. It is possible that after this test, your child may not be able
to continue on this study. The screening test results will be discussed with you.

Your child will be randomly assigned (as in the toss of a coin) to either the CTP or a
"control" group. The control group will receive standard educational support, but will not
receive the one-on-one cognitive training given during the study. After the study is
completed, patients randomized to the control group will be eligible to receive the CTP
intervention, free of charge, if the parents prefer. All participants will complete
standardized cognitive and academic tests at three time points: at the beginning of the
study, six months later, and then six months after that. The tests will be given by a very
experienced research assistant who will ask your child questions and have him or her
complete various paper and pencil tasks or puzzles. Testing at each of the three time
points will take about 3 hours. However, the test sessions can be divided into shorter
sessions, if necessary for the child's comfort. After each test session, you and your child
will talk to a member of the study staff about your child's results and what they mean to
your child's progress.

Your child will be seen for a total of 20 study-therapy visits (as long as they are in the
intervention group) over a 4 to 6 month training period. Each visit will be about two hours
long, and will occur once a week during the training period. The study visits will be
"one-on-one" sessions between your child and the therapist. Each study visit will be
include two 50-minute training sessions with a 15-minute break between them. During
training sessions, your child will participate in several activities. Each activity will
only last about 15 minutes each. If your child gets tired during a session, the therapist
will let him/her take a short rest break.

The therapy program your child receives will be especially designed for him/her, building on
his/her strengths as well as focusing on areas where he/she needs more help.

This is an investigational study. CTP and assessment appointments will be scheduled on days
that your child is already in the clinic or inpatient, as often as possible. About 30
children will take part in this study. All will be enrolled at M. D. Anderson.