Abstract
ABSTRACT
Background
Children undergoing cancer treatment experience high anxiety, procedural distress, and impaired quality of life (QoL), yet scalable psychosocial interventions remain scarce. We tested whether an augmented reality (AR)–supported, manualized cognitive behavioral therapy program (AR‐CBT; the “My Hospital Buddy Ida” application plus a workbook) improves psychosocial outcomes more than standard CBT or usual care.
Procedure
In a multicenter, three‐arm, assessor‐blinded randomized controlled trial at six recruiting sites in Türkiye, 114 children aged 6–12 years within the first 4 months of chemotherapy were randomized to AR‐CBT, standard CBT (workbook only), or usual care; both active arms received nine clinician‐delivered sessions. The primary outcome was the child‐reported Pediatric Quality of Life Inventory (PedsQL) Cancer Module total score. Pre‐specified secondary outcomes included resilience, parent‐reported behavior problems, state anxiety, parent‐proxy QoL, and anticipatory fatigue, nausea, and distress. Analyses adjusted for baseline and age.
Results
Ninety‐three children completed the trial (AR‐CBT
n
= 36; standard CBT
n
= 28; usual care
n
= 29). AR‐CBT yielded higher post‐treatment PedsQL total scores than both comparators (
F
[2,88] = 12.98,
p
η
2
= 0.23), with parallel gains across most subscales. Resilience was higher after AR‐CBT (
p
F
= 5.75,
p
= 0.004), and anticipatory fatigue, nausea, and distress all declined (
p
≤ 0.014). Acceptability was high in all arms (97.2% in AR‐CBT; between‐arm differences nonsignificant).
Conclusions
AR‐supported CBT was feasible, acceptable, and superior to standard CBT and usual care for QoL, resilience, and symptom‐related distress, supporting AR‐CBT as a scalable vehicle for evidence‐based psychotherapy in pediatric oncology.
Trial Registration
ClinicalTrials.gov: NCT07742059 (first submitted July 21, 2026, first posted August 3, 2026). Enrollment began in April 2024, so registration was retrospective. The study design and primary outcome were pre‐specified in the Institutional Review Board (IRB)‐approved protocol (2023.128.IRB1.040, approved April 12, 2023) before enrollment began.