NCT00498719

Brief Summary

Primary Objectives:

  1. 1.To evaluate the feasibility of enrolling children and adolescents with newly diagnosed brain tumors, leukemia, or lymphoma in a program designed to prevent the academic and cognitive declines that commonly result following central nervous system (CNS) disease and treatment.
  2. 2.To evaluate whether a Cognitive Training Program (CTP) might be helpful to patients in preventing attention deficits that commonly result following CNS disease and therapy.
  3. 3.To explore the relationship between CTP treatment compliance and stability/decline in cognitive and academic performance in children and adolescents who are being treated for brain tumors, leukemia, and lymphoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
17.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

20.4 years

First QC Date

July 9, 2007

Last Update Submit

December 29, 2020

Conditions

Keywords

LeukemiaLymphomaBrain TumorAttention DeficitCognitive Training ProgramCentral Nervous SystemCNSCTP

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Academic + Cognitive Decline Pre- to Post-Treatment

    Determine whether Cognitive Training Program (CTP) prevents declines in cognitive and academic skills by comparing change from pre- to post-treatment through Academic achievement tests and psychological adjustment questionnaires at three points of time (baseline, at the end of training and 6 months later)

    5 Years

Study Arms (2)

CTP Group

One-on-one cognitive training

Behavioral: Cognitive Training Program

Control Group

Standard educational support.

Other: Control Group

Interventions

Cognitive training sessions over a 4 to 6 month training period, each lasting about 2 hours.

Also known as: CTP
CTP Group

Standard educational support.

Control Group

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Participants with leukemia, lymphoma, or brain tumor that are at least 6 years old.

You may qualify if:

  • Eligibility criteria to participate in the study are: at least 6-years-old.
  • Enrolled in school or homebound instruction in a grade Kindergarten through 12th.
  • A diagnosis of leukemia, lymphoma, or brain tumor (e.g., primary brain tumors, leptomeningeal infiltration, or metastases) that requires treatment of the CNS (surgery, CRT, and/or chemotherapy).
  • Within 2 months to 14 months after beginning treatment for cancer.
  • Full scale IQ \> or = 70.
  • English-speaking. (This is defined as the ability to appropriately respond to test and training materials.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLymphomaBrain NeoplasmsAttention Deficit Disorder with Hyperactivity

Interventions

Cytidine TriphosphateControl Groups

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Martha Askins, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

April 1, 2004

Primary Completion

September 1, 2024

Study Completion

September 1, 2025

Last Updated

December 31, 2020

Record last verified: 2020-12

Locations