Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong.
Department of Paediatrics and Child Health Nursing, College of Health Sciences, Debre Markos University, Debre Markos, Ethiopia.
Trials. 2022 Sep 27;23(1):811. doi: 10.1186/s13063-022-06768-x.
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.
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.
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.
ClinicalTrials.gov NCT05270655. Registered on March 8, 2022.
儿科癌症患者常经历焦虑和抑郁。有证据表明，认知行为干预可能有助于减轻癌症治疗中的儿童的焦虑和抑郁。然而，只有少数研究评估了其对全球儿科癌症患者的心理健康和生活质量的影响。在埃塞俄比亚，迄今为止尚无已发表的研究。因此，本试验旨在评估一种文化适应性认知行为干预对接受化疗的埃塞俄比亚血液恶性肿瘤儿童的疗效。
将开展一项单盲、平行组、两臂、重复测量随机对照试验。将招募 80 名年龄在 8 至 18 岁之间、患有血液恶性肿瘤且正在接受化疗的儿童，并将其随机分配到实验组或对照组。实验组将接受五次认知行为干预介绍、识别和修正不良思维和行为、行为激活、练习深呼吸练习、重新评估目标或治疗计划，并鼓励参与者保持改变。每次会议将面对面进行，每周 30-35 分钟。对照组将接受常规护理。使用修订后的儿童焦虑和抑郁量表和儿童生活质量量表通用核心评分 4.0，在基线、干预后和干预后一个月测量结局。
本研究的结果将为将文化有效的认知行为干预策略纳入儿科肿瘤学实践提供证据，从而为文献增添新知识，并有助于改善接受化疗的血液恶性肿瘤儿童的护理。如果认知行为干预被证明有效且具有文化可接受性，它将为将干预作为儿科血液学/肿瘤学的标准护理提供证据。
ClinicalTrials.gov NCT05270655。于 2022 年 3 月 8 日注册。
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