Clinical trial NCT05270655: Cognitive-behavioural Intervention for Anxiety, Depression and Quality of Life Among Children Receiving Chemotherapy.
Official title: Effects of a Cognitive-behavioural Intervention on Anxiety, Depression and Quality of Life Among Ethiopian Children With Haematological Cancer Receiving Chemotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancy
Anxiety
Depression
Quality of Life
Keywords: Cognitive Behavioral Therapy
Anxiety
Depression
Quality of life
Children
Hematologic Malignancy
Chemotherapy
Ethiopia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 76
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, multi-center, randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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

Eligibility criteria: Inclusion Criteria:

1. 8 to 18-year-old children
2. Diagnosed with haematological cancer
3. Receiving chemotherapy
4. Able to communicate (speak, read and write) with the local language, Amharic
5. Able to provide written parental consent and oral child assent

Exclusion Criteria:

1. Have a history of developmental problems, psychological or psychiatric illness
2. Unable to collaborate in the study due to acute illness
3. Have hearing or speech problems

Primary outcomes:
measure: Change in anxiety level
timeFrame: 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 outcomes:
measure: Change in depression level
timeFrame: 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)
measure: Change in quality of life
timeFrame: 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)
Other outcomes:
measure: Satisfaction with cognitive-behavioural intervention
timeFrame: Immediately after the completion of the intervention (T1, at 6 weeks)
measure: Demographic characteristics
timeFrame: Immediately before the intervention (T0, at baseline)
Locations:
city: Addis Ababa
country: Ethiopia
facility: Tikur Anbesa specialised hospital
city: Gondar
country: Ethiopia
facility: University of Gondar specialised hospital
Study officials:
affiliation: The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong
name: Tenaw G Melesse, PhD (c)
role: PRINCIPAL_INVESTIGATOR
affiliation: The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong
name: Janita PC Chau, PhD
role: STUDY_CHAIR
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