MDACC Study Summary 2004-0126

Study Summary
No. 2004-0126:.......Brain; CNS; Leukemia; Lymphoma......Martha Askins......Pediatrics

Study Summary Title



Study Summary Number:	2004-0126

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

Physician

New Patient Referral



Name:	Martha Askins	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-4467 Contact us about clinical trials

General Information



Disease Group:	Brain CNS Leukemia Lymphoma	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Appointments of the CPT will be coordinated with the child's medical appointments. Participants will be seen for twenty weeks over the course of a six-month period of time. Wait list control patients will be seen at three time points.

Treatment Agents:	None	Home Care:	Not applicable.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Not applicable.


Description/ Intervention:	The goal of this behavioral study is to look at whether a Cognitive Training Program might be helpful to patients in preventing attention deficits that are a common result after Central Nervous System disease and therapy.

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:	04/05/2004

IRB Review and Approval Date:	03/17/2004

Study Type:	Not Applicable

Recruitment Status:	Closed

Projected Accrual:	30

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Eligibility criteria to participate in the study are: at least 6-years-old.

2) Enrolled in school or homebound instruction in a grade Kindergarten through 12th.

3) A diagnosis of leukemia, lymphoma, or brain tumor (e.g., primary brain tumors, leptomeningeal infiltration, or metastases) that requires treatment of the CNS (surgery, CRT, and/or chemotherapy).

4) Within 2 months to 14 months after beginning treatment for cancer.

5) Full scale IQ > or = 70.

6) English-speaking. (This is defined as the ability to appropriately respond to test and training materials.)

Exclusion Criteria:

1) A major physical, neurologic, or psychiaric condition that would preclude participation in the research program. The functional criteria for exclusion is inability to perceive and comprehend training materials and therapeutic interventions.

Links

Registration Number: NCT00498719
Study Information on Clinical Trials Registry (clinicaltrials.gov)