Computerized Cognitive Training for Childhood Cancer Survivors
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Computerized Cognitive Training for Childhood Cancer Survivors: A Pilot Study|
- Computer program results [ Time Frame: baseline and study completion ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Participate in 12 week computer program.
Behavioral: Captain's Log Computer Program
12 Computer Program
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629395
|United States, North Carolina|
|Duke University Health Systems|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Kristi Hardy, PhD||Duke University Health System|