Cognitive‐Behavioral Intervention for Children With Hematological Cancer Receiving Chemotherapy: A Randomized Controlled Trial

OBJECTIVE: Cognitive-behavioral intervention (CBI) has shown positive effects in improving psychological and health-related outcomes in children with cancer. However, no evidence has been found in Ethiopia. This study aimed to evaluate the effects of CBI on anxiety, depression and quality of life (QoL) in Ethiopian children with hematological cancer receiving chemotherapy. METHODS: A parallel, two-armed, assessor-blinded, randomized controlled trial was conducted among 76 children randomized (1:1) to receive CBI or usual medical care. The intervention group received five weekly face-to-face CBI sessions of 30-40 min each, which included an introduction to CBI; identifying and challenging maladaptive thoughts, beliefs and behavior; behavior activation; deep breathing exercises; and treatment evaluation and relapse prevention. The outcomes were measured at baseline (T0), immediately post-intervention (T1) and 1 month post-intervention (T2). RESULTS: The intervention group showed a significant reduction in anxiety scores from T0 at T1 (β = -6.67, 95% CI [-9.16, -4.19], p < 0.001) and T2 (β = -8.14, 95% CI [-10.70, -5.57], p < 0.001), depression at T1 (β = -4.09, 95% CI [-6.94, -1.23], p = 0.005) and T2 (β = -6.12, 95% CI [-9.10, -3.13], p < 0.001) and improvement in QoL at T2 (β = 3.02, 95% CI [0.49, 5.56], p = 0.019) compared with the control group. CONCLUSIONS: CBI has positive effects in reducing anxiety and depression and in improving QoL in children with hematological cancer receiving chemotherapy. The results suggest the need to incorporate CBI into pediatric hematology-oncology and studies on its long-term effects and cost-effectiveness are warranted. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05270655). Registered on 08 March 2022.