An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-induced Constipation (OIC) in Patients With Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,007
- 试验地点
- 16
- 主要终点
- Prevalence of opioid-induced constipation
研究概览
简要总结
The aim of the project is to investigate opioid-induced constipation (OIC) in a real world / diverse group of patients with cancer.
The objectives of the project are to determine: a) prevalence of OIC; b) clinical features / impact of OIC; c) management of OIC.
详细描述
StOIC-1 is an observational study, and will involve a single visit (see below for schedule).
The following data will be collected: a) demographic data - age, gender, ethnicity; b) cancer diagnosis; c) opioid medications - drug, formulation, dose; d) laxative medications - drug, formulation, dose; e) other medications; f) Eastern Co-operative Oncology Group performance status
The participants will be asked the following questions:
- Simple question - "Are you constipated?" [Options - yes / no / unsure]
- European Association for Palliative Care definition question - "Does the following question describe your bowel function: 'the passage of small, hard faeces infrequently and with difficulty?' [Options - yes / no / unsure]
- Camilleri definition question - "Does the following statement describe your bowel function: 'a change since initiating opioid therapy from baseline bowel habits that is characterised by any of the following: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, harder stool consistency?' [Options - yes / no / unsure
- Rome IV diagnostic criteria for OIC
The participants will also be asked to complete:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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 > 18yr; diagnosis of cancer; diagnosis of cancer pain; receipt of regular opioids for at least one week
排除标准
- •Inability to give informed consent; inability to complete questionnaire
结局指标
主要结局
Prevalence of opioid-induced constipation
时间窗: 1 week
Clinician assessment
次要结局
未报告次要终点
