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

NCT01217996 | Completed

• 2 other identifiers: COGTRN120421-RSGPB-11-009-01-CPPB
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor; Acute Lymphoblastic Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 10 weeks, and 6 months

Secondary Outcomes (2)

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

  6 months.

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

  Baseline and 10 weeks.

Study Arms (2)

Intervention Group

OTHER

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

Behavioral: Computerized working memory training program (intervention)

Control Group

OTHER

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

Behavioral: Computerized working memory training program (control)

Interventions

Computerized working memory training program (intervention) BEHAVIORAL

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 Group

Computerized working memory training program (control) BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Brain Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Memory Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Heather M Conklin, Ph.D

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 8, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 29, 2014

Record last verified: 2014-04

Locations

US (1)