Efficacy of Psychological Intervention for Children With Cancer

Not Applicable

Not yet recruiting

• Conditions: Clinical Depression; Clinical Anxiety; Quality of Life
• Interventions: Behavioral: Interventiion or CBT Group

• Registration Number: NCT06620445
• Lead Sponsor: Pakistan Institute of Medical Sciences

Brief Summary

The study will be conductued at the Pediatric Oncology Department of the Children's Hospital, PIMS Islamabad, over the peroid of six months. This single-blinded, two-arm RCT study will involve 80 children aged 8 to 16 years with maligancies recieving chemotherapy. Participants will be randomly allocated to either interventional or CBT group which will recieve weekly five sessions of Cognitive Behaviour Therapy (CBT) or the control group, which will recieve the usual care. CBT session will be contducted by Clinical Psychologist will last 30-35 minutes. Outcomes will be measured at Baseine and one month post intervention using Revised Child Anxiety and Depression Scale (RCADS) and Pediatric Quality of Life Generic Core Score 4.0.

Detailed Description

Background:

Children with cancer and their families experience various psychosocial challenges during and after treatment, including physical and cognitive changes due to medical treatment, alterations in social and familial roles, and the potential threat of death.

While most children and families cope and adjust well to the diagnosis and treatment of cancer, a subset of children is at increased risk for anxiety, depression, educational, and relationship difficulties. Caregivers and siblings of pediatric patients are also at risk for heightened distress and post-traumatic stress. Psychosocial care and interventions can play an important role in supporting the well-being of the entire family, beginning at diagnosis.

The psychological impact of cancer on Pakistani children is diverse and far-reaching, ranging from concerns about their future to worries about appearing different from their peers. Given the high prevalence of psychological difficulties among pediatric cancer patients in Pakistan, it is essential to determine the effectiveness of interventions offered to support their mental health and well-being. Studies on cancer patients related to their psychiatric problems are already rare in Pakistan.

Objective:

The main objective of this study is to compare the effect of psychological intervention, such as cognitive-behavioral therapy (CBT), to the routine care given among pediatric oncology patients. The findings of this study will provide evidence to support the integration of psychological intervention strategies into pediatric oncology practice, thus adding new knowledge to the literature and helping improve the care of children with malignancies receiving chemotherapy.

Study Design:

The study will be conducted at the Pediatric Oncology Unit, PIMS, Islamabad. This study will be a two-armed longitudinal, randomized control trial expected to run for six months. Children with malignancy receiving chemotherapy will be recruited and randomly assigned to experimental or control groups.

Intervention:

The experimental group will receive five sessions of cognitive-behavioral intervention, where maladaptive thoughts and behavior will be identified, behavioral activation will be encouraged, and deep breathing exercises will be practiced. The control group will receive the usual care.

Recruitment and Sample:

The recruitment process will involve the random selection of children diagnosed with malignancies and undergoing treatment at the Pediatric Oncology Unit, the Children's Hospital PIMS Islamabad, Pakistan.

Outcome Measures:

The outcomes will be measured at baseline, post-intervention, and one month after the intervention using the Revised Child Anxiety and Depression Scale and Pediatric Quality of Life Inventory Generic Core Score 4.0.

Data Analysis:

Data analysis will be conducted using SPSS version 23.

Ethical Considerations:

Permission to conduct the study will be acquired from the Ethical Review Board (ERB) of PIMS Islamabad.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-26
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Study Start: 2024-10-10
• Primary Completion: 2025-02-10
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Children aged 16-18 years
2. Diagnosed with malignancy
3. Recieving chemotherapy at the Pediatric Oncology Department of PIMS Islamabad
4. Able to understand and participate in CBT sessions
5. Parent/Caregiver consent and child assent

Exlusion Criteria:

1. Children with severe cognitive impairment or intellectual disability
2. Children with a comorbid medical conditions
3. Children whose parents or caregivers are unable to provide consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Group	Interventiion or CBT Group	The Intervention or CBT group included 40 children aged 8-16 years with malignancies recieving chemotherapy. They will recieve weekly five sessions of CBT (30-35 minutes per session)

Primary Outcome Measures

Name	Time	Method
Revised Child Anxiety and Depression Scale (RCADS)	Baseline (before the intervention) and one month post intervention (after the five weekly sessions of CBT)	The RCADS is a standardized, self reported scale measuring anxiety and depression symptoms among children aged 8-18 years.

Secondary Outcome Measures

Name	Time	Method
Pediatric QoL	Baseline and one month post intervention	It evaluates physical, emotional, social and school funtioning.

Trial Locations

Locations (1)

Muhammad Wasim Khan; 🇵🇰 Islamabad, Pakistan