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

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.

Conditions

• Hematologic Malignancy
• Anxiety
• Depression
• Quality of Life

Interventions

OTHER

Cognitive-behavioural intervention

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).

Sponsors & Collaborators

• Chinese University of Hong Kong

  lead OTHER

Principal Investigators

• Tenaw G Melesse, PhD (c) · The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

• Janita PC Chau, PhD · The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-12

Primary Completion

2022-10-20

Completion

2022-10-20

Countries

• Ethiopia

Study Locations