Cognitive Intervention at the End of Therapy for Survivors of Childhood ALL Treated on TOTXVI
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 77
Summary
- Conditions
- Acute Lymphoblastic Leukemia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomized to either the intervention group to receive cognitive training or to the standard of care group who will not receive cognitive training.Masking: Single (Outcomes Assessor)Masking Description: The study examiner (clinical research assistants or psychological examiners) will not know which group of participants is associated with each arm.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 4 years and 125 years
- Gender
- Both males and females
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 work...
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).
Tracking Information
- NCT #
- NCT03187977
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lisa M. Jacola, PhD St. Jude Children's Research Hospital
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