A Cross-sectional Study to Investigate the Pain Control Status in Cancer Patients in South East Asian Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 462
- 主要终点
- Prescription Pattern of Analgesics (Opioid or Non-opioid)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Prescription Pattern of Analgesics (Opioid or Non-opioid)
时间窗: 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.
Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators
时间窗: Day 1
The scale used to measure a patient's satisfaction with pain control ranges from 1 to 5: 1. Very satisfied 2. Satisfied 3. Acceptable 4. Dissatisfied 5. Very dissatisfied Patients and Investigators will each indicate their opinion on separate scales.
Intensity of Pain Currently and Over Past 24 Hours as Measured by NRS Scores Indicated by Patient
时间窗: 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.
Quality of Life as Measured Using EQ-5D-3L Questionnaire Answered by Patient
时间窗: 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.
次要结局
- Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient(Past 7 days up to Day 1)
- Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale(Day 1)