Cognitive-behavioural Intervention for Anxiety, Depression and Quality of Life Among Children Receiving Chemotherapy.
Condition: Hematologic Malignancy; Anxiety; Depression; Quality of Life
MeSH terms: Neoplasms; Hematologic Neoplasms; Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      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: 
      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;

        1. Significantly decreased anxiety at the end of the intervention

        2. Significantly decreased depression at the end of the intervention

        3. Significantly increased quality of life at the end of the intervention
    

Intervention name(s): Cognitive-behavioural intervention
Intervention type(s): Other
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blind, multi-center, randomised controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cognitive Behavioral Therapy; Anxiety; Depression; Quality of life; Children; Hematologic Malignancy; Chemotherapy; Ethiopia