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Computerized Intervention for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors

Primary Purpose

Brain Tumor, Acute Lymphoblastic Leukemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Computerized working memory training program (intervention)

Computerized working memory training program (control)

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring working memory intervention, memory impairment, cognitive late effects, Childhood Cancer Survivors

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria for Screening Phase:

Received CNS-directed treatment (intrathecal chemotherapy or cranial irradiation) for a BT or ALL
Infratentorial tumor location (for the BT cohort)
Off treatment for at least one year with no evidence of recurrent or progressive disease
Age 8-16 years inclusive at the time of enrollment
English as the primary language
Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines

Exclusion Criteria for Screening Phase

Significant impairment in global intellectual functioning (estimated or full scale IQ < 70 based on standardized testing routinely conducted on primary treatment protocols)
History of CNS injury/disease predating or unrelated to cancer diagnosis
Documented ADHD predating cancer diagnosis
Treatment with psychostimulant or psychotropic medication within two weeks of study participation
Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures/photosensitive epilepsy, psychosis)

Inclusion Criteria for Intervention Phase

Signed screening consents and has undergone screening
Fully evaluable psychological testing results (including IQ > or = 70)
Age-scaled score on Digit Span, Letter-Number Sequencing or Spatial Span < 7 OR at least one standard deviation below IQ score
Training aide is available to participate in required sessions
Participant and training aide demonstrate computer proficiency
Participant has access to or will be provided a laptop or home computer with internet connection and speakers
Participant willing to participate in required aspects of computerized intervention
Participant is able to take part in fMRI without sedation

Exclusion Criteria for Intervention Phase

Major psychological condition that would preclude completion of protocol intervention (e.g., significant oppositionality, autism spectrum disorder, severe anxiety or depressive symptoms)
Orthodontic appliances that cause MRI distortion or signal loss outside the mouth and sinus area

Sites / Locations

St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Intervention Group

Control Group

Arm Description

Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) will complete the computerized working memory training program (intervention).

Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) will complete the computerized working memory training program (control).

Outcomes

Primary Outcome Measures

This study will measure working memory, attention and executive functions

Participants in the working memory intervention will demonstrate significantly greater improvement from pre- to immediate post-intervention on performance- and rater-based measures of working memory relative to childhood cancer survivors placed on an intervention waitlist.

Secondary Outcome Measures

The study will measure the maintenance of improvements on measures of working memory, attention and executive functions

The improvements will be evaluated at six months following participation in the computer-based intervention program.

This study will examine the neural correlates of working memory before and immediately after intervention

This objective will use fMRI to examine the neural correlates of working memory before and immediately after intervention.

Full Information

NCT ID

NCT01217996

First Posted

October 7, 2010

Last Updated

April 28, 2014

Sponsor

St. Jude Children's Research Hospital

Collaborators

American Cancer Society, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01217996

Brief Title

Computerized Intervention for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors

Official Title

Computerized Intervention for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Jude Children's Research Hospital

Collaborators

American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) show elevated rates of working memory impairment. Working memory (WM) is the ability to hold and manipulate information online; for example, when an individual mentally rehearses a phone number in order to dial it without writing it down. A computer-based working memory intervention has been successful in children diagnosed with ADHD and stroke survivors. Individuals participating in the intervention showed improvements on working memory measures as well as more complex problem solving skills. Neuroimaging (brain scans) conducted before and after training showed changes in brain activation suggestive of underlying changes in brain systems that support working memory. This study investigates the effectiveness of this computer-based working memory intervention for childhood cancer survivors.

Detailed Description

Participants randomized to the intervention arm will complete the computerized working memory training program. This computer-based training program is completed in the home and requires approximately 30 minutes every weekday for five weeks. The program software guides the child through eight rotating exercises each day, with increasing difficulty based on the child's level of performance. Exercises train both visuospatial and verbal WM using child-friendly activities. A research team member will serve as a coach who monitors weekly progress online and offers support through weekly phone calls with the study participants and their caregivers. This individual will not complete post-intervention assessments to maintain study blind. A home computer with internet connection and speakers is required. A laptop computer and/or wireless internet access will be provided to families whose only obstacle to participation is lack of computer access or internet connectivity in the home setting. Families randomized to the WM intervention will complete a tutorial with study staff that provides instruction in using a computer, the internet and the WM training software. The objective of this study is to investigate the benefits of this working memory intervention in a sample of childhood cancer survivors and look at brain-based changes that may occur as the result of working memory intervention. To achieve this goal, we plan to study childhood cancer survivors randomly assigned to the working memory intervention or a passive waitlist. Both groups will participate in cognitive testing pre-, post-, and six months post intervention. Intervention participants will also partake in neuroimaging exams before and after the intervention. Findings from this study have direct potential to support a nonpharmaceutical cognitive intervention for cancer survivors that is a safe and effective alternative to stimulant medications with great promise for improving quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Tumor, Acute Lymphoblastic Leukemia

Keywords

working memory intervention, memory impairment, cognitive late effects, Childhood Cancer Survivors

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Other

Arm Description

Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) will complete the computerized working memory training program (intervention).

Arm Title

Control Group

Arm Type

Other

Arm Description

Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) will complete the computerized working memory training program (control).

Intervention Type

Behavioral

Intervention Name(s)

Computerized working memory training program (intervention)

Intervention Description

A computer-based training program will be completed in the home. This program requires approximately 30 minutes every weekday for five weeks. The program software guides the child through eight rotating exercises each day, with increasing difficulty based on the child's level of performance. Exercises train both visuospatial and verbal WM using child-friendly activities. A research team member will serve as a coach who monitors weekly progress online and offers support through weekly phone calls with the study participants and their caregivers). Intervention participants will also partake in neuroimaging exams before and after the intervention

Intervention Type

Behavioral

Intervention Name(s)

Computerized working memory training program (control)

Intervention Description

Participants randomized to the control group will not complete any intervention during the intervention time period and will not partake in neuroimaging exams. They will complete an immediate and six month post follow-up cognitive assessment. Following completion of these assessments, they will be provided the opportunity to complete the computer-based training program off study.

Primary Outcome Measure Information:

Title

This study will measure working memory, attention and executive functions

Description

Time Frame

Baseline, 10 weeks, and 6 months

Secondary Outcome Measure Information:

Title

The study will measure the maintenance of improvements on measures of working memory, attention and executive functions

Description

The improvements will be evaluated at six months following participation in the computer-based intervention program.

Time Frame

6 months.

Title

This study will examine the neural correlates of working memory before and immediately after intervention

Description

This objective will use fMRI to examine the neural correlates of working memory before and immediately after intervention.

Time Frame

Baseline and 10 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for Screening Phase: Received CNS-directed treatment (intrathecal chemotherapy or cranial irradiation) for a BT or ALL Infratentorial tumor location (for the BT cohort) Off treatment for at least one year with no evidence of recurrent or progressive disease Age 8-16 years inclusive at the time of enrollment English as the primary language Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines Exclusion Criteria for Screening Phase Significant impairment in global intellectual functioning (estimated or full scale IQ < 70 based on standardized testing routinely conducted on primary treatment protocols) History of CNS injury/disease predating or unrelated to cancer diagnosis Documented ADHD predating cancer diagnosis Treatment with psychostimulant or psychotropic medication within two weeks of study participation Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures/photosensitive epilepsy, psychosis) Inclusion Criteria for Intervention Phase Signed screening consents and has undergone screening Fully evaluable psychological testing results (including IQ > or = 70) Age-scaled score on Digit Span, Letter-Number Sequencing or Spatial Span < 7 OR at least one standard deviation below IQ score Training aide is available to participate in required sessions Participant and training aide demonstrate computer proficiency Participant has access to or will be provided a laptop or home computer with internet connection and speakers Participant willing to participate in required aspects of computerized intervention Participant is able to take part in fMRI without sedation Exclusion Criteria for Intervention Phase Major psychological condition that would preclude completion of protocol intervention (e.g., significant oppositionality, autism spectrum disorder, severe anxiety or depressive symptoms) Orthodontic appliances that cause MRI distortion or signal loss outside the mouth and sinus area

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heather M Conklin, Ph.D

Organizational Affiliation

St. Jude Children's Research Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Jude Children's Research Hospital

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.stjude.org

Description

St. Jude Children's Research Hospital

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Computerized Intervention for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors

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