Computerized Cognitive Training for Childhood Cancer Survivors

May 31, 2013 updated by: Duke University

Computerized Cognitive Training for Childhood Cancer Survivors: A Pilot Study

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participate in 12 week computer program.
Behavioral: Captain's Log Computer Program
12 Computer Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Computer program results
Time Frame: baseline and study completion
baseline and study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Kristi Hardy, PhD, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (Estimate)

March 6, 2008

Study Record Updates

Last Update Posted (Estimate)

June 3, 2013

Last Update Submitted That Met QC Criteria

May 31, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00001502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Brain Tumor

Clinical Trials on Captain's Log Computer Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe