Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 11
- 主要终点
- Change in quality of life according SF-12 questionnaire
研究概览
简要总结
In the context of radiotherapy, control of breakthrough pain represents a special challenge. Patients undergoing radiotherapy may experience different situations of pain that may be due to the need to remain immobilized during radiotherapy session, the need to wear an immobilization mask (head and neck cancer), the odynophagia caused by mucositis, defecation after the development of proctitis, or sudden pain during the night causing sleep disturbances.
In a survey conducted in radiation oncology services more than half of patients treated with radiotherapy experienced pain, and 39% of patients reported that their pain was not treated properly. This situation may increase the patient's anxiety, dissatisfaction with treatment, affect their quality of life and can even come to refuse radiotherapy treatment.
This post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in radiotherapy 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
- •Cancer Patients
- •Patients attended in radiation oncology consultations with palliative intent
- •Life expectancy > 6 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
- •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
Change in quality of life according SF-12 questionnaire
时间窗: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
Change in punctuation of the SF-12 questionnaire between end of radiotherapy treatment and baseline.
次要结局
- Mean duration of the episodes of breakthrough pain(Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment)
- Change in assessment (percentage) of family claudication(Baseline and 4-6 weeks (estimated end of radiotherapy treatment))
- Patient Global improvement(4-6 weeks (estimated end of radiotherapy treatment))
- Percentage of patients with neuropathic, visceral, somatic and mixed pain(Baseline (the day that patient sign the informed consent form))
- Clinical Global improvement(4-6 weeks (estimated end of radiotherapy treatment))
- Change in mean Intensity of breakthrough cancer pain at each study visit(Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment)
- Change in MOS Sleep Scale scores(Baseline and 4-6 weeks (estimated end of radiotherapy treatment))
- Comorbidities associated with patients(Baseline (the day that patient sign the informed consent form))
- Mean time to relief of breakthrough pain(Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment)