Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,765
- 试验地点
- 36
- 主要终点
- Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation
研究概览
简要总结
The purpose of this study is to determine the prevalence of breakthrough cancer pain and characterize breakthrough cancer pain in an unselected, representative cohort of cancer outpatients with or without pain who attend consultations.
详细描述
This study has been designed as a non-interventional, non post-authorization, cross-sectional, epidemiological study to determine the prevalence of breakthrough cancer pain and characterize breakthrough cancer pain in an non-selected, representative cohort of cancer outpatients with or without pain.
The study enrolled 3765 patients. This multicenter trial will be conducted in Spain. Data from participants will be collected through questionnaire and medical history in a single visit (up to 1 month).
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
- •Participants≥ 18 years old
- •Participants with baseline cancer pain that is adequately controlled with opioids
- •Presence of episodes of breakthrough pain associated with the cancer pain
- •Meeting the diagnostic criteria for breakthrough cancer pain (participant history and Portenoy's criteria) and the Davies algorithm
- •Participants who are not receiving treatment for breakthrough cancer pain. It is not permitted the inclusion of participants receiving treatment for breakthrough cancer pain in order to avoid bias that may affect the characterization or taxonomy of breakthrough cancer pain
- •Signing of the informed consent
排除标准
- •Severe mental illness
- •Any medical condition or situation complicating the collection of study data as determined by the investigator
结局指标
主要结局
Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation
时间窗: Month 1
Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation
时间窗: Month 1
Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
次要结局
- Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation(Month 1)
- Pain Assessment Using the Numeric Rating Scale(Month 1)
- Pain Characterization With the Alberta Breakthrough Pain Assessment(Month 1)
- Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire Score(Month 1)
- Participant's Performance as Assessed by the Karnofsky Scale Score(Month 1)
- Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation(Month 1)
- Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score(Month 1)