Computerized Cognitive Training for Childhood Cancer Survivors
Primary Purpose
Primary Brain Tumor
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Captain's Log Computer Program
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Brain Tumor focused on measuring pediatric, brain tumor, survivors
Eligibility Criteria
Inclusion Criteria:
- 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
- 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:
- Estimated IQ ≤ 70
- Motor, visual, or auditory handicap that prevents computer use
- A diagnosis of attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), depression, autism, or pervasive developmental disorder (PDD)
- 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.
Sites / Locations
- Duke University Health Systems
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Participate in 12 week computer program.
Outcomes
Primary Outcome Measures
Computer program results
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00629395
Brief Title
Computerized Cognitive Training for Childhood Cancer Survivors
Official Title
Computerized Cognitive Training for Childhood Cancer Survivors: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Specific Aim 1: To assess the feasibility and acceptability of a home-based, computerized attention training program with survivors of central nervous system (CNS) impacting pediatric cancer (e.g. acute lymphocyte leukemia [ALL], brain tumors).
Specific Aim 2: To estimate the effect size of this attention training program with survivors of childhood cancer to determine whether a larger-scale clinical trial is warranted.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Brain Tumor
Keywords
pediatric, brain tumor, survivors
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participate in 12 week computer program.
Intervention Type
Behavioral
Intervention Name(s)
Captain's Log Computer Program
Intervention Description
12 Computer Program
Primary Outcome Measure Information:
Title
Computer program results
Time Frame
baseline and study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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:
Estimated IQ ≤ 70
Motor, visual, or auditory handicap that prevents computer use
A diagnosis of attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), depression, autism, or pervasive developmental disorder (PDD)
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristi Hardy, PhD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health Systems
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Computerized Cognitive Training for Childhood Cancer Survivors
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