Validation of a Screening Scale for the Misuse of Opioid Analgesics in Patients With Chronic Pain Related to Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- POMI scale score - Prescription Opioid Misuse Index
研究概览
简要总结
In oncology, pain is one of the main symptoms of discomfort. It has a significant impact on the quality of life.The use of opioid analgesics is recommended for the treatment of moderate to severe cancer pain.The misuse of opioid analgesics is an international public health problem.Different scales have been developed to help the prescriber screen for the risk of misuse in the general population. Patients with cancer-related pain are also at risk for aberrant opioid-related behaviors, misuse or addiction.
The main objectif of this study is to validate of the screening scale for the misuse of opioid analgesics in patients with chronic pain related to cancer. (Prescription Opioid Misuse Index - POMI).
详细描述
The study takes place in 2 phases.
Test phase :
Questionnaire no. 1 constitutes the data for the TEST phase: it includes socio-demographic data, medical and family history, lifestyle, treatments, 5 questions from the Concise Pain Questionnaire (QCD), the French version of the POMI scale, the diagnostic criteria of the DSM-V and two questions concerning anxiety associated with pain and therapeutic education.
Retest phase :
questionnaire no. 2 10 to 15 days later.
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 aged 18 and over,
- •Patients with chronic cancer-related pain that has been evolving for at least 3 months,
- •Patients with a regular prescription of at least one opioid analgesic medicine taken daily for at least 1 month,
- •Patients followed in oncology for an active cancerous pathology.
排除标准
- •Stopping opioid prescriptions on the day of the test phase (no Retest possible),
- •Patients in the process of weaning (risk of being weaned during the Retest phase),
- •Patients unable to complete the questionnaire on their own,
- •Patients followed in a pain or addiction centre,
- •Patients in terminal palliative situations of their cancer,
- •Patients with chronic pain that is more disabling than cancer-related pain,
- •Patients refusing to participate,
- •Patients under guardianship or curatorship,
- •Pregnant or breastfeeding patients,
- •Patient with a language barrier limiting understanding of the questionnaire in French.
结局指标
主要结局
POMI scale score - Prescription Opioid Misuse Index
时间窗: day 15
8-item self-assessment scale
次要结局
- Sociodemographic characteristics(day 1)
- QCD(day 15)
- Lifestyle habits, other consumption(day 1)
- Analgesic treatments(day 1)
- Use of analgesics(day 15)