Analgesic Treatment for Cancer Pain in South East Asia (ACE)
2016年9月8日 更新者：Mundipharma Pte Ltd.
A Cross-sectional Study to Investigate the Pain Control Status in Cancer Patients in South East Asian Countries
This study is planned to investigate the pain control status in cancer patients in 6 South East Asian countries through evaluation of prescription pattern of analgesics, satisfaction of pain control, quality of life and assessment of the adequacy of pain control and relationship among these factors in cancer patients with pain.
Cancer pain is undermanaged and it is hoped that this study will be used as a reference for effective cancer pain management in these countries.
研究概览
研究类型
观察性的
注册 (实际的)
462
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Subjects were selected from government and private hospitals that see cancer patients.
描述
Inclusion Criteria:
- Adult (over 18 years) cancer patients [country variation would be accepted based on the definition of adults]
- Cancer has been diagnosed pathologically
- Out-patients with cancer pain due to cancer itself or its treatment
- Patients being treated with any analgesics for more than one month for the management of cancer pain at enrolment
- Patients who are willing to voluntarily sign the study consent form
Exclusion Criteria:
- Patients who have had an operation for any reasons within 3 months prior to the enrolment
- Patients with any oncologic emergency
- Patients who had any interventional therapy (e.g. nerve block, neurolytic procedures) related to their cancer pain within 6 weeks of study entry
- Insufficient ability or willingness to cooperate
- Patients who are judged not suitable to participate in this study by the investigator
- Patients who are participating in any other interventional clinical trials for cancer treatment or supportive care
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients receiving cancer pain treatment
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Prescription Pattern of Analgesics (Opioid or Non-opioid)
大体时间：Day 1
|
At Visit 1 (Day 1) which was the only visit in the study, data was collected on whether each patient was receiving only opioid, only non-opioid or both opioid and non-opioid analgesic treatments for pain control.
|
Day 1
|
|
Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators
大体时间：Day 1
|
The scale used to measure a patient's satisfaction with pain control ranges from 1 to 5:
Patients and Investigators will each indicate their opinion on separate scales. |
Day 1
|
|
Quality of Life as Measured Using EQ-5D-3L Questionnaire Answered by Patient
大体时间：Day 1
|
EQ-5D-3L summary indices were calculated using the algorithm developed based on the valuation of EQ-5D-3L health states from an adult Thai population (Tongsiri & Cairns, 2011).
Applying the Thai algorithm, EQ-5D-3L summary indices range from -0.45 to 0.80, with an EQ-5D-3L summary index of 0.80 indicating the best overall health-related quality of life.
|
Day 1
|
|
Intensity of Pain Currently and Over Past 24 Hours as Measured by NRS Scores Indicated by Patient
大体时间：Past 1 day up to Day 1
|
Patients indicated their pain intensity using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Their current pain intensity and pain in the last 24 hours were indicated on separate scales. A higher score indicates higher pain intensity. |
Past 1 day up to Day 1
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient
大体时间：Past 7 days up to Day 1
|
Patients answered "yes" or "no" to the following question: "Have you had trouble sleeping due to your cancer pain within the last 7 days?" |
Past 7 days up to Day 1
|
|
Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale
大体时间：Day 1
|
The Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale ranges from 0 to 4: 0- Fully active, able to carry on all pre-disease performance without restriction
A higher score indicates greater functional impairment. |
Day 1
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Thinh DHQ, Sriraj W, Mansor M, Tan KH, Irawan C, Kurnianda J, Nguyen YP, Ong-Cornel A, Hadjiat Y, Moon H, Javier FO. Analgesic Prescription Patterns and Pain Outcomes in Southeast Asia: Findings From the Analgesic Treatment of Cancer Pain in Southeast Asia Study. J Glob Oncol. 2018 Sep;4:1-10. doi: 10.1200/JGO.17.00055.
- Thinh DHQ, Sriraj W, Mansor M, Tan KH, Irawan C, Kurnianda J, Nguyen YP, Ong-Cornel A, Hadjiat Y, Moon H, Javier FO. Patient and Physician Satisfaction with Analgesic Treatment: Findings from the Analgesic Treatment for Cancer Pain in Southeast Asia (ACE) Study. Pain Res Manag. 2018 Apr 18;2018:2193710. doi: 10.1155/2018/2193710. eCollection 2018.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年9月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2016年1月22日
首先提交符合 QC 标准的
2016年1月22日
首次发布 (估计)
2016年1月27日
研究记录更新
最后更新发布 (估计)
2016年10月31日
上次提交的符合 QC 标准的更新
2016年9月8日
最后验证
2016年9月1日
更多信息
与本研究相关的术语
其他研究编号
- OPD14-AP-401
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.