Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00498719 |
| Other study ID # |
2004-0126 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2004 |
| Est. completion date |
September 2025 |
Study information
| Verified date |
December 2020 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Primary Objectives:
1. To evaluate the feasibility of enrolling children and adolescents with newly diagnosed
brain tumors, leukemia, or lymphoma in a program designed to prevent the academic and
cognitive declines that commonly result following central nervous system (CNS) disease
and treatment.
Hypothesis 1: Despite the rigors of disease and treatment, children and adolescents will
be able to participate in the CTP while they are receiving treatment for cancer. The
high participation of our patients in routine school activities during treatment
suggests that they will have the energy and interest required to participate in
cognitive training.
2. To evaluate whether a Cognitive Training Program (CTP) might be helpful to patients in
preventing attention deficits that commonly result following CNS disease and therapy.
Hypothesis 2: Patients in the CTP arm of the study will show fewer declines in
neurocognitive performance at the end of training and again six months later, as
compared with the control group who will receive the usual services provided by the
Education Program in Pediatrics.
3. To explore the relationship between CTP treatment compliance and stability/decline in
cognitive and academic performance in children and adolescents who are being treated for
brain tumors, leukemia, and lymphoma.
Hypothesis 3: Level of compliance with CTP treatment will be predictive of a patient's
performance on neurocognitive measures.
Description:
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.
