Cognitive-behavioural Intervention for Anxiety, Depression and Quality of Life Among Children Receiving Chemotherapy.

Study Overview
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Brief Summary
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The diagnosis and treatment of paediatric cancer is the most stressful experience for children and their families. Nearly all paediatric cancer patients are presented with at least one psychosocial problem, of which, anxiety and depression often coexist and are most frequently reported. Poorly managed anxiety and depression causes emotional and behavioural problems, impairs relationships and functioning, decreases adhere to treatment, increases the burden of symptoms and significantly impacts quality of life and prognosis. Despite the high rates and negative impacts of anxiety and depression in paediatric oncology, they are poorly managed. Thus, to mitigate the burden of anxiety, depression and impaired quality of life, an age-appropriate cognitive-behavioural intervention shows promise when incorporated with the existing pharmacologic interventions. This study aims to test how effective cognitive-behavioural intervention is to improve anxiety, depression and quality of life of children during chemotherapy. The study will be conducted in two hospitals in Ethiopia and include 8-18-year-old children with haematological cancer receiving chemotherapy, able to communicate with the local language, Amharic, able to provide parental consent and child assent, and without history of developmental, psychological, psychiatric, hearing or speech problems. The study will enroll up to 80 participants and randomise them into two groups, one group will receive a cognitive-behavioural intervention and the the other group will receive the usual psychosocial care provided by staff nurses. Participants in the cognitive-behavioural intervention group will receive five sessions of individual face to face cognitive-behavioural intervention. Each session will last approximately 30-35 minutes a week and supplemented by home-based practices. This study will use different intervention delivery strategies including psychoeducation, guided discovery or Socratic questioning, discussion, drawing, painting or writing, and play depending on the content of each session and maturity of the child. The levels of anxiety, depression and quality of life will be measured before the intervention, after the intervention and one month after completion of the intervention in both groups.

Detailed Description
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The application of cognitive-behavioural therapy (CBT) has been used for the management of anxiety and depression. Nowadays, evidence suggests that CBT has promising effects on improving psychological and health-related outcomes in children with cancer. CBT is a structured, and tailored psychotherapeutic intervention based on cognitive and behavioural approaches that helps to understand the underlying thoughts, feelings, and behaviours that mitigate between the course of the illness and the outcomes. It helps to modify dysfunctional thoughts and beliefs, reduce maladaptive behaviour and increase adaptive skills. It enables the patients to control their emotions and behaviour, to become their own therapist, to make the interventions sustainable and prevent relapse. A systematic review and meta-analysis conducted shows cognitive-behavioural therapy has been used to manage stressful experiences including anxiety and depression among children during the course of cancer treatment. However, the studies included heterogenous participants across the cancer trajectory and employed different intervention delivery strategies. Additionally, majority of the included studies didn't specify the theory guiding the intervention development. Thus, developing and evaluating theory driven and age appropriate cognitive-behavioural intervention strategies for children undergoing chemotherapy is worthy of research. In this study, the Beck's cognitive model will be adopted to develop theory driven and age appropriate effective cognitive-behavioural intervention strategies for children receiving chemotherapy. The model was selected based on the results of the systematic review and other literatures on CBT. The model describes the interactions among cognition, affection, and behaviour. Accordingly, it is not only the stressor but the perceptions and beliefs of the individual, and interpretation of a particular stressor that affect the emotional, physiological, and behavioural responses. Children with cancer usually have negative perceptions and thoughts about the self and others, the illness, and treatments such as chemotherapy. These distorted thoughts and negative strategies are often associated with emotional disturbances such as anxiety and depression. Cognitive-behavioural intervention helps to identify and modify distorted thought and behaviour, and develop cognitive and behavioural adaptations to improve emotional and behavioural responses. Cognitive adaptation is mainly achieved through cognitive restructuring such as identifying and challenging distorted thoughts and misinterpretations and developing coping strategies. Behavioural adaptation is largely achieved through behavioural activation such as identifying and introducing joyful activities. Changes in cognitive processes and developing adaptive behavioural activities increases coping strategies and reduces anxiety and depression symptoms, increase psychosocial functioning and quality of life due to improvement in stressful symptoms. This study aims to evaluate the effects of a theory-based cognitive behavioural-intervention on anxiety, depression and quality of life among Ethiopian children with haematological cancer receiving chemotherapy. In this study, it is hypothesised that when compared to the control group, participants receiving a cognitive-behavioural intervention will have; Significantly decreased anxiety at the end of the intervention Significantly decreased depression at the end of the intervention Significantly increased quality of life at the end of the intervention

Official Title
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Effects of a Cognitive-behavioural Intervention on Anxiety, Depression and Quality of Life Among Ethiopian Children With Haematological Cancer Receiving Chemotherapy.

Conditions
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Hematologic Malignancy, Anxiety, Depression, Quality of Life

Intervention / Treatment
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* Other: Cognitive-behavioural intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 8 to 18-year-old children Diagnosed with haematological cancer Receiving chemotherapy Able to communicate (speak, read and write) with the local language, Amharic Able to provide written parental consent and oral child assent Exclusion Criteria: Have a history of developmental problems, psychological or psychiatric illness Unable to collaborate in the study due to acute illness Have hearing or speech problems

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind, multi-center, randomised controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-behavioural intervention<br>Five sessions of cognitive-behavioural intervention will be delivered on a weekly basis. | Other: Cognitive-behavioural intervention<br>* Participants in the experimental group will receive five sessions of cognitive-behavioural intervention. Each session will be conducted face-to-face for 30-35 minutes a week and supplemented by home-based practices. The first session is an introductory to cognitive-behavioural intervention, the second session includes identifying, evaluating and challenging maladaptive thoughts, beliefs and behaviour, the third session includes behavioural activation, the fourth session is deep breathing, and the last session includes treatment evaluation and relapse prevention. The interventions will be delivered before chemotherapy sessions to avoid fatigue and to increase the patient's engagement with the interventions. To establish a strong therapeutic alliance and enhance intervention delivery and family support, parents will be invited to attend the introduction of the first session and the summary of each session (the last five minutes).<br>|
| No Intervention: Usual care<br>Participants in the control group will receive the usual psychosocial care provided by the staff nurses. To offer them attention, a research assistant in each hospital will meet them every week for 30 minutes to ask them about treatment adherence and any other concerns. The parents will be invited to attend it if they want to do so. Each participant will be given an appointment slip and reminded with a phone call two days before the next appointment. For participants whose medical appointment is more than a week, the research will contact them via phone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety level | Anxiety and depression will be assessed using a self-report 25-items (15-items for anxiety and 10-items for depression) Revised Child Anxiety and Depression Scale (RCADS). Each item will be rated on a four-point Likert scale (0-3) and the total score will be calculated by converting the row scores into T-scores. T scores of ≥65 to 70 and ≥ 70 show borderline clinical threshold and above clinical threshold respectively. The higher anxiety sub-scale score refers higher anxiety. | At three time points; before the intervention (T0, baseline), immediately after the intervention (T1, at 6 weeks) and one month after completion of the intervention (T2, at 10 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression level | A self-report 25-items items Revised Child Anxiety and Depression Scale (RCADS) will be used to assess the level of depression. The higher depression sub-scale score refers to higher depression level. | At three time points; before the intervention (T0, baseline), immediately after the intervention (T1, at 6 weeks) and one month after completion of the intervention (T2, at 10 weeks) | 
| Change in quality of life | Quality of life will be assessed using a child-report Quality of Life Inventory Generic Core Score 4.0 (PedsQLTM 4.0 GCS) for ages (8-12 and 13-18). Each item will be scored on a five-point Likert scale (0-4). The total score will be calculated reversely scoring the 0-4 scale items and linearly transforming to 0-100. A higher score indicates higher quality of life. | At three time points; before the intervention (T0, baseline), immediately after the intervention (T1, at 6 weeks) and one month after completion of the intervention (T2, at 10 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy, Anxiety, Depression, Quality of life, Children, Hematologic Malignancy, Chemotherapy, Ethiopia