Cognitive Intervention at the End of Therapy for Survivors of Childhood ALL Treated on TOTXVI

March 24, 2022 updated by: St. Jude Children's Research Hospital

Cognitive Intervention at the End of Therapy for Survivors of Childhood ALL Treated on TOTXVI: A Pilot Study

Computer-based cognitive training has been found to be helpful for improving attention and working memory in pediatric and adult patients with existing cognitive difficulties. A previous study was conducted at St. Jude Children's Research Hospital with survivors of childhood cancer who were experiencing difficulties with attention and/or working memory. Findings from that study indicated that the use of Cogmed, computer-based cognitive training, is effective in improving attention and working memory in survivors.

Researchers want to learn whether Cogmed intervention completed at the end of therapy for acute lymphoblastic leukemia will be effective for all survivors (i.e., regardless of whether they have existing difficulties).

PRIMARY OBJECTIVES:

  • To evaluate the overall participation rate in a randomized, standard-of-care controlled trial of computerized cognitive intervention administered at the end of TOTXVI therapy.
  • To estimate the study completion rate in a randomized, standard-of-care controlled trial of computerized cognitive intervention administered at the end of TOTXVI therapy.
  • To estimate the compliance rate for participants randomized to the intervention arm of a computerized cognitive intervention administered at the end of TOTXVI therapy.
  • To estimate the standard deviation for the overall cohort on a measure of working memory.
  • To use neuroimaging data collected in the context of the Total Therapy XVI trial to explore candidate biomarkers predictive of response to the computerized cognitive intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants enrolled on the TOTXVI protocol at SJCRH will be randomized to either complete the Cogmed intervention at the end of their therapy, or to a standard-of-care condition.

Cogmed is a computer-based cognitive training program that consists of rotating exercises that train attention and working memory. The exercises are presented in a child-friendly, game-like format. Training is completed at home in 25 sessions for 15-45 minutes each weekday for 5-9 weeks. A research team member serves as a coach who monitors progress and provides support through weekly phone calls with study participants and their parents/guardians. Information regarding compliance and performance is tracked over the internet and used to tailor feedback during weekly telephone coaching.

Neurocognitive assessments will be conducted at baseline, immediate-post (3-4 months after baseline), and 8 month follow-up (12 months after baseline).

Study Type

Interventional

Enrollment (Actual)

50

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
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

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

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Currently enrolled and receiving treatment for acute lymphoblastic leukemia (ALL) on the TOTXVI therapy protocol at St. Jude Children's Research Hospital
  • At least 4 years of age at the time of randomization
  • Primary language is English
  • Parent/legal guardian/caregiver that speaks English available to assist in participant's training

Exclusion Criteria:

  • Significant cognitive impairment as determined by either an IQ of ≤ 70 or by clinician judgment
  • Major sensory or motor impairment that would preclude valid cognitive testing
  • Major psychological condition that would preclude completion of the intervention
  • History of significant CNS injury or disease predating or unrelated to cancer diagnosis
  • Documented ADHD predating cancer diagnosis

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive Training
Participants will participate in computer-based cognitive training at the end of therapy.
Behavioral: Cognitive training
Cogmed is a computer-based cognitive training program that consists of rotating exercises that train attention and working memory. The exercises are presented in a child-friendly, game-like format. The program is completed at home for 15-45 minutes each weekday for 5-9 weeks.
Other Names:
  • Cogmed
No Intervention: Standard-of-Care
At the end of therapy, participants will participate in the current standard-of-care which does not include computer-based cognitive training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in working memory
Time Frame: Prior to intervention (baseline) and post intervention (up to one year later)
The magnitude and standard deviation of pre- to post-change in Spatial Span Backward will be estimated for each group and for the overall group.
Prior to intervention (baseline) and post intervention (up to one year later)

Collaborators and Investigators

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

Sponsor

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Lisa M. Jacola, PhD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

August 3, 2017

Primary Completion (Actual)

October 13, 2021

Study Completion (Actual)

October 13, 2021

Study Registration Dates

First Submitted

June 13, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 15, 2017

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALLCOG
  • NCI-2017-01276 (Registry Identifier: NCI Clinical Trial Registration Program)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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