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

NCT05270655 | Completed

• 1 other identifier: CREC Ref. No.: 2021.729-T
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematologic Malignancy; Anxiety; Depression; Quality of Life

Keywords

Cognitive Behavioral Therapy; Anxiety; Depression; Quality of life; Children; Hematologic Malignancy; Chemotherapy; Ethiopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in 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

  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 (2)

• Satisfaction with cognitive-behavioural intervention

  Immediately after the completion of the intervention (T1, at 6 weeks)

• Demographic characteristics

  Immediately before the intervention (T0, at baseline)

Study Arms (2)

Cognitive-behavioural intervention

EXPERIMENTAL

Five sessions of cognitive-behavioural intervention will be delivered on a weekly basis.

Other: Cognitive-behavioural intervention

Usual care

NO INTERVENTION

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.

Interventions

Cognitive-behavioural intervention OTHER

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).

Cognitive-behavioural intervention

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Tikur Anbesa specialised hospital

Addis Ababa, Ethiopia

Location

University of Gondar specialised hospital

Gonder, Ethiopia

Location

Related Publications (17)

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• Melesse TG, Li WHC, Chau JPC, Yimer MA, Gidey AM, Yitayih S. Cognitive-Behavioral Intervention for Children With Hematological Cancer Receiving Chemotherapy: A Randomized Controlled Trial. Psychooncology. 2025 Jan;34(1):e70086. doi: 10.1002/pon.70086.

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• Melesse TG, Chau JPC, Li WHC. Efficacy of a culturally tailored cognitive-behavioural intervention for Ethiopian children with haematological malignancies: study protocol for randomised controlled trial. Trials. 2022 Sep 27;23(1):811. doi: 10.1186/s13063-022-06768-x.

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MeSH Terms

Conditions

Hematologic Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Tenaw G Melesse, PhD (c)

  The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Janita PC Chau, PhD

  The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Single-blind, multi-center, randomised controlled trial

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: March 8, 2022
• Study Start: April 12, 2022
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ET (2)