Efficacy of Psychological Intervention for Children With Cancer: A Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Revised Child Anxiety and Depression Scale (RCADS)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants (Children/Guaddians or Parents) are unaware of which group they are assigned (CBT group or usual care group). Researcher are aware of the group assignments.
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 16-18 years
- •Diagnosed with malignancy
- •Recieving chemotherapy at the Pediatric Oncology Department of PIMS Islamabad
- •Able to understand and participate in CBT sessions
- •Parent/Caregiver consent and child assent
- •Exlusion Criteria:
- •Children with severe cognitive impairment or intellectual disability
- •Children with a comorbid medical conditions
- •Children whose parents or caregivers are unable to provide consent
排除标准
- 未提供
结局指标
主要结局
Revised Child Anxiety and Depression Scale (RCADS)
时间窗: 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.
次要结局
- Pediatric QoL(Baseline and one month post intervention)
研究者
Dr. Muhammad Wasim Khan
Dr. Muhammad Wasim Khan
Pakistan Institute of Medical Sciences