NCT01310387已完成3 期
A Randomized Prospective Controlled Study of Active Pain Management in Lung Cancer Outpatients (APM)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- The percent of pain intensity difference
研究概览
简要总结
This study is:
- A single-center, randomized, prospective controlled trial.
- To prove superiority of active pain management group compared to control group by the percent of pain intensity difference of outpatients with lung cancer pain.
- 204 patients will be recruited.
详细描述
-
The recruited patients in both group will be provided the education about pain-killer, and received medicines including opioids according to their numeric rating scale (NRS)
-
Active management group will be provided additional telephone counseling and dosage modification by specialized nurse for cancer pain.
-
The percent of pain intensity difference (%PID)
-
PID = (NRS of visit 1 - NRS of visit 3)/NRS of visit 1
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with lung cancer.
- •The patients with uncontrolled lung cancer pain - more than and equal NRS 4 pain during previous 24 hours for background pain, or more than and equal 3 times/day for breakthrough painkiller medication.
- •Over 20 year-old male or female.
- •The patients can be able to received telephone counseling by investigator's decision.
排除标准
- •Drug or alcohol abusers.
- •Child-bearing women or pregnant women.
- •The patients with moderate to severe psychiatric problems.
- •The patients who have hypersensitivity to opioids.
结局指标
主要结局
The percent of pain intensity difference
时间窗: visit 3 (6 to 8 weeks)
The percent of pain intensity difference (%PID) %PID = (NRS of visit 1 - NRS of visit 3)/NRS of visit 1
次要结局
- Eastern Cooperative Oncology Group (ECOG) Performance score(visit 3 (6 to 8 weeks))
- Patients' satisfaction score about pain management(visit 3 (6 to 8 weeks))
- Assessment of Korean Brief Pain Inventory score(visit 3 (6 to 8 weeks))
- Investigator's global assessment score(visit 3 (6 to 8 weeks))
研究者
Young-Chul Kim
Professor
Chonnam National University Hospital
研究点 (1)
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