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Completed

NCT Number: NCT03187977

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

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.

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Key information

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive training

Behavioral

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 15, 2017
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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