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Computerized Cognitive Training for Childhood Cancer Survivors: A Pilot Study


N/A
9 Years
17 Years
Not Enrolling
Both
Primary Brain Tumor

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Trial Information

Computerized Cognitive Training for Childhood Cancer Survivors: A Pilot Study


Pediatric patients meeting initial eligibility criteria will be identified through the
databases for each clinic (n = approximately 50 survivors in each clinic). A letter
explaining the purpose of the study will then be sent to the parents of these patients.
Interested parents will be invited to contact study personnel by phone or email for a
thorough review of the study and to schedule a screening appointment.

After obtaining written informed consent and assent (from parents and child, respectively),
screening procedures will include administration of an abbreviated intellectual test
battery, two working memory tasks, and a computerized attention measure to the survivor.
Parents will complete questionnaire measures regarding their child's adaptive, behavioral,
emotional, and attentional functioning; follow-up interviewing will be conducted to clarify
any potential problems identified on the questionnaires. The entire screening procedure is
estimated to take approximately 60 minutes for the survivor and 30-45 minutes for parents.
To maximize efficiency, a research assistant will complete testing with the child and a
psychologist will explain the questionnaire measures to the parent and conduct any follow-up
interviewing.


Inclusion Criteria:



1. A T-score greater than the 75th percentile on either the Cognitive
Problems/Inattention or the DSM-IV Inattention subscales of the Conners' Parent
Rating Scale

2. One or more standard deviations below the mean on the Working Memory Index of the
WISC-IV or a Working Memory Index that is one or more standard deviations below the
participant's estimated IQ.

These criteria are based on the eligibility criteria used in the largest trial to date of
psychostimulant methylphenidate (MPH; commonly known as Ritalin) with survivors of
childhood cancer.

Exclusion Criteria:

1. Estimated IQ ≤ 70

2. Motor, visual, or auditory handicap that prevents computer use

3. A diagnosis of attention-deficit hyperactivity disorder (ADHD), oppositional defiant
disorder (ODD), depression, autism, or pervasive developmental disorder (PDD)

4. Insufficient fluency in English.

Participants who are currently taking stimulant medications (stable dose for at least 30
days) for attentional difficulties, but who meet inclusion criteria will be allowed to
participate.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Computer program results

Outcome Time Frame:

baseline and study completion

Safety Issue:

No

Principal Investigator

Kristi Hardy, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System

Authority:

United States: Institutional Review Board

Study ID:

Pro00001502

NCT ID:

NCT00629395

Start Date:

June 2007

Completion Date:

October 2010

Related Keywords:

  • Primary Brain Tumor
  • pediatric
  • brain tumor
  • survivors
  • Brain Neoplasms

Name

Location

Duke University Health Systems Durham, North Carolina  27710