Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Medical Oncology Services
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 14
- 主要终点
- Changes in quality of life of the patients
研究概览
简要总结
In cancer patients, pain is one of the most common symptoms. The range of reported prevalence of pain varies from 33% to 64% including different stages of cancer, during or after anticancer treatment. Moreover, despite the optimal management of basal chronic pain, 66% of these patients have reported breakthrough pain which has a severe impact on quality of life. There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in medical oncology services according to routine clinical practice. For this reason we consider it is appropriate to prospectively evaluate the quality of life of cancer patients with cancer breakthrough pain in medical oncology services as well as other factors that can affect quality of life. This post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in medical oncology services in Spanish hospitals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients > 18 years
- •Patients with histologically confirmed neoplasia
- •Patients attended in medical oncology consultations
- •Life expectancy > 3 months
- •Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm
- •Written informed consent
排除标准
- •Untreated patients with opioids for baseline pain
- •Patients who are not opioid tolerant
- •Serious psychiatric disorder or any disease or condition that prevents the collection of data
- •Patients with evidence of opioid addiction or history of drug or alcohol abuse
结局指标
主要结局
Changes in quality of life of the patients
时间窗: Up to 4 weeks
Changes according to EQ-5D-5L questionnaire
次要结局
- Characteristics of patients(At baseline)
- Management of cancer breakthrough pain.(Up to 4 weeks)
- Anxiety and depression status and the possible relationship between these factors and quality of life.(Up to 4 weeks)
- Sleep quality and the possible relationship between this factor and quality of life.(Up to 4 weeks)
- Evaluate caregivers effort(Up to 4 weeks)
- Perceived assistance quality by patients(Up to 4 weeks)
- Improvement impression perceived by patients(Up to 4 weeks)