NCT00629395

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

3.3 years

First QC Date

February 27, 2008

Last Update Submit

May 31, 2013

Conditions

Primary Brain Tumor

Keywords

pediatricbrain tumorsurvivors

Outcome Measures

Primary Outcomes (1)

  • Computer program results

    baseline and study completion

Study Arms (1)

1

EXPERIMENTAL

Participate in 12 week computer program.

Behavioral: Captain's Log Computer Program

Interventions

Captain's Log Computer ProgramBEHAVIORAL

12 Computer Program

1

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health Systems

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Kristi Hardy, PhD

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 6, 2008

Study Start

June 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

US(1)