A Randomized, Controlled Clinical Study: Assess and Intervene Cancer Pain of Advanced Malignant Tumor Patients in Real-Time, Using the Real-time Cancer Pain Assessment and Intervention System Based on Cloud Computing Concept.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- pain intensity
研究概览
简要总结
This study aim at the advanced malignant tumor patients who suffer from cancer pain, investigate the current status of cancer pain treatment, and study the effects in pain control and quality of life improvement using the method of real-time monitoring and treatment instruction of cancer pain. This study is a randomized, controlled, single center clinical study. After recruitment, the subjects will randomly assign to standard cancer pain treatment group and standard cancer pain treatment plus real-time dynamic monitoring and treatment intervention of cancer pain using the cloud computing concept system. And then, assess the alleviation of cancer pain and quality of live. The assumption is the system will alleviate the cancer pain efficiently.
详细描述
- Cancer pain is a common symptom exists in malignant tumor patients, which bother the patients and decrease the quality of life.
- The goal of the study is that using the real-time monitoring and intervention system will alleviate cancer pain better than the standard cancer pain treatment.
- The cloud computing concept is developed by Sun Yat-sen University cancer center, and accord with clinical practice.
- The subjects receive the real-time monitoring and intervention system will install the software and report in the contents of cancer pain in the software correspondingly to the doctors, and advices will be given by the software as well.
- The quality of life and overall survival follow-up is also required.
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
- •Solid tumors confirmed by pathology or cytology
- •Eastern Cooperative Oncology Group Performance Status: 0-2
- •sign the informed consent form
- •good compliance, willing to comply with the requirements of the study
- •anticipate survival time more than 3 months
- •pain intensity is greater than 2 points according to numerical rating scale on enrollment; have indication of opioid analgesic drugs.
- •can express subjective feelings of pain intensity clearly.
- •own a smartphone or tablet device which can install and use the application program software, and can operate the software proficiently.
排除标准
- •poor compliance, refuse to sign the informed consent form, or difficult to comply with the requirement of the study.
- •slight pain or no pain, no indication of opioid analgesic drugs.
- •contraindication of opioid analgesic drugs
- •no other medical workers give instructions during the study.
结局指标
主要结局
pain intensity
时间窗: up to 9 weeks
the numeric rating scale and visual analogue scale of pain during the chemotherapy. using brief pain inventory scales. in this case, once 2 days in intervention group; once a weeks in control group; and a comprehensive cancer pain assessment according to national comprehensive cancer network adult pain guidance every cycle. within 3 weeks after withdraw, all of the statistics will be analyzed.
duration of pain
时间窗: up to 9 weeks
the numeric rating scale and visual analogue scale of pain during the chemotherapy. using brief pain inventory scales. in this case, once 2 days in intervention group; once a weeks in control group; and a comprehensive cancer pain assessment according to national comprehensive cancer network adult pain guidance every cycle. within 3 weeks after withdraw, all of the statistics will be analyzed.
次要结局
- quality of life(change from baseline of quality of life at 6 weeks)
研究者
Li Zhang
Professor
Sun Yat-sen University