Quality of Life Study in Patients With Cancer Breakthrough Pain Treated in Palliative Care Units
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 10
- 主要终点
- Change in quality of life according EORTC QLQ-C30 questionnaire
研究概览
简要总结
Patients treated in Palliative Care Units are potentially fragile patients, especially in our case, which are cancer patients. The management of these patients is usually done from experience, because these patients rarely meet criteria for clinical trials, as their inclusion could affect results obtained in the trial.
There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in palliative care units 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 treated in palliative care units as well as the characteristics of these patients.
This post-authorization observational study will assess the quality of life of patients with breakthrough cancer pain treated in Palliative Care Units 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 advanced cancer
- •Patients attended in Palliative Care Units
- •Life expectancy> 3 months
- •Written informed consent
- •Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm
排除标准
- •Serious psychiatric disorder, cognitive impairment 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
Change in quality of life according EORTC QLQ-C30 questionnaire
时间窗: Baseline and 4 weeks
Change in punctuation of the EORTC QLQ-C30 questionnaire between week 4 and baseline.
次要结局
- Patient Global improvement(Week 4)
- Change in mean Intensity of breakthrough cancer pain at each study visit(Up to 4 weeks, from date of inclusion until week 4)
- Mean time to relief of breakthrough pain(Up to 4 weeks, from date of inclusion until week 4)
- Mean duration of the episodes of breakthrough pain(Up to 4 weeks, from date of inclusion until week 4)
- Percentage of fragile patients at study entry(Baseline)
- Comorbidities associated with patients(Baseline (the day that patient sign the informed consent form))
- Percentage of patients with neuropathic, visceral, somatic and mixed pain(Baseline (the day that patient sign the informed consent form))
- Cognitive impairment(Baseline)