An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid Induced Constipation (OIC) in European Patients With Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Prevalence of opioid induced constipation (OIC)
研究概览
简要总结
Constipation is common (40-90%) in advanced cancer patients , and has a significant negative impact on quality of life. The aetiology of constipation is often multifactorial in advanced cancer patients. However, it is well recognised that opioid analgesics are a common cause of constipation in this group. The prevalence of opioid-induced constipation (OIC) is stated to be 40-70%, although a recent large study reported an even higher figure.
OIC has been reported to exceed pain in terms of distress caused, and studies have found that some patients choose to reduce or discontinue opioid medication in order to attempt to better control constipation. Moreover, OIC is associated with a variety of physical (gastrointestinal, systemic), psychological and social problems.
详细描述
This European study follows on from a United Kingdom study, and aims to confirm findings of the previous study in a larger, more heterogeneous sample: it also aims to explore additional strategies to manage OIC. Moreover, the study aims to identify differences in perception of normal bowel habit / constipation, and differences in OIC management in the different European countries. Previous studies suggest that there are cultural differences in people's beliefs about constipation / normal bowel function. The aim of the project is to investigate OIC in a real world / heterogenous group of European patients with cancer.
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
- •Age 18 years or over
- •Diagnosis of cancer
- •Diagnosis of cancer pain or cancer treatment-related pain
- •Taking regular opioids for at least one week (i.e. opioid for mild to moderate pain / "weak" opioid; or opioid for moderate to severe pain / "strong" opioid)
排除标准
- •Unable to provide consent
- •Unable to complete questionnaire
结局指标
主要结局
Prevalence of opioid induced constipation (OIC)
时间窗: 5 minutes
OIC diagnosed using Rome IV diagnostic criteria
次要结局
- Efficacy of treatment for OIC(3 minutes)
- Impact of OIC on quality of life(5 minutes)
- Adherence with treatment for OIC No scale - yes / no options(5 minutes)
- Use of non-prescribed treatments for OIC(5 minutes)
研究者
Prof Andrew Davies
Professor of Palliative Medicine
University of Dublin, Trinity College