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

St. Jude Children's Research Hospital

Status

Completed

Conditions

Acute Lymphoblastic Leukemia

Treatments

Behavioral: Cognitive training

Study type

Interventional

Funder types

Other

Identifiers

NCT03187977

NCI-2017-01276 (Registry Identifier)

ALLCOG

Details and patient eligibility

About

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.

Full 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).

Enrollment

50 patients

Sex

All

Ages

4+ years old

Volunteers

No Healthy Volunteers

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