A Prospective Study on Psychological Distress at Diagnosis and During Treatment in Pediatric Acute Lymphoblastic Leukemia Patients and Their Parents in India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Quality of life of patients newly diagnosed with ALL (PedsQLTM scores – total and each in different domains) at diagnosis and after one month of treatment completion with their correlation.
研究概览
简要总结
This study focuses on children aged 5 to 18 years newly diagnosed with acute lymphoblastic leukemia and their parents in India. It aims to assess psychological distress and quality of life at diagnosis and one month after starting treatment. Using standard tools like PedsQL questionnaire for pediatric patients and WHOQOL-BREF questionnaire for parents/caregivers of patients, the study will measure emotional and social impacts, identify related sociodemographic factors, and evaluate changes over time of one month of starting treatment. Conducted at Gujarat Cancer and Research Institute over 12 months, the research involves 100 child-caregiver pairs and uses statistical analysis to understand correlations between patient and caregiver well being.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 5.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Pediatric patients aged 5–18 years, newly diagnosed with Acute Lymphoblastic Leukemia admitted at Pediatric oncology unit.
- •Child and parent or caregiver must be able to understand and respond to assessment tools in the provided languages.
排除标准
- •Children previously diagnosed with known pre-existing psychiatric illness/developmental delay/genetic disorder.
- •Caregiver previously diagnosed with known pre-existing psychiatric illness/mood disorders/genetic disorders/1st degree relative with psychiatric illness
- •Children requiring intensive treatment in intensive care unit at the time of diagnosis.
结局指标
主要结局
Quality of life of patients newly diagnosed with ALL (PedsQLTM scores – total and each in different domains) at diagnosis and after one month of treatment completion with their correlation.
时间窗: At the time of diagnosis and after one month of treatment completion
次要结局
- Quality of life of parents/caregivers of patients with ALL (WHOQOL-BREF scores – total & each in different domains) at diagnosis & after one month of treatment completion with their correlation.(Correlation of psychological distress & quality of life measured by PedsQLTM & WHOQOL-BREF scores with clinical/sociodemographic factors.)
研究者
Dr Maharshi Trivedi
Gujarat Cancer and Research Institute