Efficacy of a culturally tailored cognitive-behavioural intervention for Ethiopian children with haematological malignancies: study protocol for randomised controlled trial

Background: Paediatric cancer patients often experience anxiety and depression. Evidence suggests that cognitive-behavioural interventions may help reduce anxiety and depression in children undergoing cancer treatment. However, only a few studies evaluated its impact on the psychological well-being and quality of life of paediatric cancer patients globally. In Ethiopia, there has been no published study to date. Thus, this trial aims to evaluate the efficacy of a culturally tailored cognitive-behavioural intervention for Ethiopian children with haematological malignancies receiving chemotherapy.

Methods: A single-blinded, parallel-group, two-arm, repeated measure randomised controlled trial will be conducted. Eighty children aged 8 - 18 years with haematological malignancy receiving chemotherapy will be recruited and randomly assigned to experimental or control groups. The experimental group will receive five sessions of introducing cognitive-behavioural intervention, identifying and modifying maladaptive thoughts and behaviour, behavioural activation, practising deep breathing exercises, reassessing goals or treatment plans, and encouraging participants to maintain changes. Each session will be conducted face-to-face for 30-35 min a week. The control group will receive usual care. The outcomes will be measured at baseline, post-intervention, and one month after the intervention using the Revised Child Anxiety and Depression Scale and Paediatric Quality of Life Inventory Generic Core Score 4.0.

Discussion: The findings of this study will provide evidence to support the integration of culturally effective cognitive-behavioural intervention strategies into paediatric oncology practice and thus, add new knowledge to the literature and help improve the care of children with haematological malignancies receiving chemotherapy. If the cognitive-behavioural intervention is shown to be effective and culturally acceptable, it will provide evidence to include the intervention as a standard of care in paediatric haematology/oncology.

Trial registration: ClinicalTrials.gov NCT05270655. Registered on March 8, 2022.