Clinical trial · Interventional
Cognitive Intervention at the End of Therapy for Survivors of Childhood ALL Treated on TOTXVI
Cognitive Intervention at the End of Therapy for Survivors of Childhood ALL Treated on TOTXVI: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cognitive Training
- description
- Participants will participate in computer-based cognitive training at the end of therapy.
- interventionNames
- Behavioral: Cognitive training
- type
- NO_INTERVENTION
- label
- Standard-of-Care
- description
- At the end of therapy, participants will participate in the current standard-of-care which does not include computer-based cognitive training.
Primary outcomes (1)
- measure
- Change in working memory
- timeFrame
- Prior to intervention (baseline) and post intervention (up to one year later)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available