Clinical trial NCT06620445: Efficacy of Psychological Intervention for Children With Cancer
Official title: Efficacy of Psychological Intervention for Children With Cancer: A Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clinical Depression
Clinical Anxiety
Quality of Life
Keywords: Psychological Intervention
Pediatric Cancer
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2024-10-01
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This single-blinded, two-arm randomized controlled trial will involve 80 children aged 8-16 with malignancies receiving chemotherapy.

Participants will be randomly assigned to either the experimental group, which will receive five weekly sessions of cognitive-behavioral intervention, or the control group, which will receive usual care. Each intervention session will last 30-35 minutes.

Outcomes will be measured at baseline and one-month post-intervention using the Revised Child Anxiety and Depression Scale and Pediatric Quality of Life Inventory Generic Core Score 4.0.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Eligibility Criteria:

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

Primary outcomes:
measure: Revised Child Anxiety and Depression Scale (RCADS)
timeFrame: Baseline (before the intervention) and one month post intervention (after the five weekly sessions of CBT)
Secondary outcomes:
measure: Pediatric QoL
timeFrame: Baseline and one month post intervention
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Muhammad Wasim Khan
Study officials:
References: