Cross-cultural Adaptation and Validation of the Pediatric Chemotherapy-induced Neuropathy (P-CIN) for Chinese Pediatric Oncology Patients: A Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 2
- 主要终点
- Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale
研究概览
简要总结
The goal of this study was to conduct a cross-cultural adaptation of the P-CIN into the Chinese context, assess its psychometric properties, and determine the cut-off value of CIPN among Chinese pediatric oncology patients.
Participants provided demographic and clinical characteristics, and complete the translated P-CIN, Wong-baker FACES Pain Rating scale for pain, and Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module for quality of life.
详细描述
A methodological, descriptive study was conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) 6 to 18 years of age
- •(2) were diagnosed with cancer
- •(3) had received or were currently receiving neurotoxic chemotherapy drugs (e.g., Vincristine, Cisplatin, Carboplatin, Oxaliplatin, Paclitaxel, Docetaxel, Ixabepilone, Bortezomib, Thalidomide)
- •(4) were able to communicate, read, and write in Chinese without significant hearing and vision problems to ensure they understood the P-CIN.
排除标准
- •(1) had a diagnosis of cancer in the central nervous system (CNS) cancer, cancer relapse or secondary cancer
- •(2) in the terminal stage
- •(3) planned to receive multiple cancer treatment (e.g., radiotherapy and immunotherapy)
- •(4) suffered from other neuromuscular diseases (e.g., traumatic brain injury and cerebral palsy)
- •(5) had a developmental deficit (e.g., Down's syndrome and other chromosomal disorders)
- •(6) have suffered from psychiatric diseases or used antipsychotic drugs
- •(7) had peripheral neuropathy symptoms caused by diabetes, genetic diseases, spinal cord injury, or alcoholism, or
- •(8) had other neuromuscular disorders (e.g., traumatic brain injury, cerebral palsy).
结局指标
主要结局
Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale
时间窗: Baseline
For measuring participants' peripheral neuropathy induced by chemotherapy. The total score ranges from 0 to 65 with higher scores indicating more severe chemotherpay induced peripheral neuropathy.
次要结局
未报告次要终点
研究者
Dr Eva Ho
Associate professor
The Hong Kong Polytechnic University