Computerized Cognitive Training for Childhood Cancer Survivors

Primary Brain Tumor Clinical Trial

Official title:

Computerized Cognitive Training for Childhood Cancer Survivors: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00629395
• Other study ID #: Pro00001502
• Status: Terminated
• Phase: N/A
• First received: February 27, 2008
• Last updated: May 31, 2013
• Start date: June 2007
• Est. completion date: October 2010

Study information

• Verified date: May 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 17 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Primary Brain Tumor

Intervention

Behavioral:
• Captain's Log Computer Program
12 Computer Program

Locations

Country	Name	City	State
United States	Duke University Health Systems	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Computer program results		baseline and study completion	No