A Randomized Controlled, Open Clinical Trial of a Web-based Platform for Multifactorial Intervention in Cancer Pain Management
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patient's average pain level (derived from the Brief Pain Scale)
研究概览
简要总结
Malignant tumors are one of the major public health problems in China, and cancer pain is a common symptom in tumor patients, affecting the quality of life. In rural areas, cancer pain management is challenging due to insufficient medical resources and limitations in understanding cancer pain. Investigators plan to develop a convenient patient self-reporting applet to help participants report their symptoms to primary care physicians promptly and monitor pain levels and medication in real-time. This project aims to improve the efficiency of cancer pain management, integrate cancer pain into chronic disease management, improve the quality of healthcare services for rural participants, and promote the construction of a healthy China.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with tumors that are confirmed by pathological findings.
- •Presence of tumor-related pain that is moderate or higher and requires intervention with morphine-based pain medication (++).
- •Have a life expectancy of more than 6 months.
- •Understand and sign a consent to participate in the study, or if the patient is unable to understand the study, his/her direct caregiver must have a good understanding of the study.
排除标准
- •Presence of other chronic non-cancer pain/have an unresolved pain-related condition.
- •Moderately severe cognitive impairment/cognitive impairment.
- •Have schizophrenia or other psychiatric illness.
- •Neither the patient nor his/her direct caregiver can understand how to use the Cancer Pain Management applet.
- •Being pregnant.
结局指标
主要结局
Patient's average pain level (derived from the Brief Pain Scale)
时间窗: From patient enrollment to 3 months, during which time the applet was used once a week
The Brief Pain Inventory (BPI) is a validated tool for assessing pain intensity and impact on daily life. The BPI consists of two parts: the first part assesses the intensity of pain using a scale of 0 to 10, where 0 indicates no pain and 10 indicates the worst pain; the second part assesses the impact of pain on various aspects of the patient's life (e.g., mood, work, sleep, and social activities). The BPI is simple and easy to use, and can help healthcare professionals to quickly obtain quantitative information about pain and monitor the effectiveness of pain management.
次要结局
- Mood and physical state of the patient (derived from the EQ-5D scale)(From patient enrollment to 3 months, during which time the applet was used twice a week)
- Burden situation of family members (derived from the Family Support Scale)(From patient enrollment to 3 months, during which time the applet was used twice a week)
- Patient quality of life (derived from the QLQ-C30 core quality of life questionnaire)(From patient enrollment to 3 months, during which time the applet was used twice a week)
研究者
Xingchen Peng
PhD, Professor
West China Hospital