Clinical trial · Interventional
Feasibility/Acceptability of Attentional-Control Training in Survivors
FAACTS: Feasibility/Acceptability of Attentional-Control Training in Survivors
NCT05528939CI-TRIAL-00084536FAACTSrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a multicenter pilot randomized controlled trial, with an active control condition, of the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a cohort of survivors of acute lymphoblastic leukemia or brain tumor ages 8-16 who are \> 1 year from the end of therapy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Attention Difficulties | — | UNRESOLVED | — |
| Cognitive Deficit in Attention | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Pediatric Brain Tumor | Childhood Brain Neoplasm | ALIAS | 0.90 |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control video game | Other | — | UNRESOLVED |
| EndeavorRx | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EndeavorRx
- description
- Children will be asked to begin digital attentional control training at home within 6 weeks of baseline testing and to complete 6 training missions per day (25-30 minutes), 5 days per week, for 4 weeks (total = 120 training missions).
- interventionNames
- Device: EndeavorRx
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- An active control program designed to replicate aspects of the intervention (e.g., regular use of digital device to access fun educational activities) while engaging cognitive skills not particularly involving attention.
- interventionNames
- Other: Control video game
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 8-16 years at time of screening. * History of diagnosis of acute lymphoblastic leukemia (ALL) or brain tumor (BT). * At least 1 year from completion of planned therapy and stable from a disease standpoint. * Participating child and caregiver are fluent in spoken English. * Availability of a caregiver who is willing and capable of providing support and supervision during cognitive training. * Participating child is either not taking any prescribed stimulant medication for attention difficulties or has been prescribed a stable dose of stimulant medication for attention difficulties for at least 30 days prior to enrollment. * Only patients with a T-score ≥ 75th percentile on the CPT-3 Omission Errors scale or on the BRIEF-2 Cognitive Regulation Index will be randomized. Exclusion Criteria: * A history of photosensitive seizures. * A motor, visual, or auditory handicap that prevents computer use. * A mental health condition that precludes, or takes treatment precedence over, participation in the cognitive training. * Participants identified during the baseline assessment as having a full-scale IQ \< 80, as estimated by WASI-II (Vocabulary and Matrix Reasoning), will not be randomized.
References
Publications (0)
Data not yet available
No reference posted for this study.