Role of the Clinical Pharmacist in an Oncology Ambulatory Center to Prevent Drug Related Problems Before Antitumor Treatment Initiation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Prevalence of Pharmacist intervention
研究概览
简要总结
The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.
The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases. The primary endpoint is the prevalence of pharmacist interventions among patients who are going to receive an oral targeted therapy or cancer chemotherapy or immunotherapy
详细描述
The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.
The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases.
The primary endpoint is the prevalence of pharmacist interventions among cancer patients who are going to receive an oral targeted therapy (140 patients) or cancer chemotherapy or immunotherapy (300 patients).
Pharmacist interventions will be classified according to the SFPC (société française de pharmacie Clinique) classification.
The secondary endpoints are
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
- •legal age patients
- •Affiliated to social security or with another insurance system
- •with a solid tumor
- •who are going to receive an antitumor treatment (chemotherapy, immunotherapy or oral targeted therapy)
排除标准
- •pregnant women
- •minor patient
结局指标
主要结局
Prevalence of Pharmacist intervention
时间窗: up to 1 week from date of inclusion
Percentage of patients whom antitumora treatment or usual treatment has been changed by the pharmacist intervention
次要结局
- Detection of Drug -drug interactions(up to 1 week from date of inclusion)
- Potential cost of the avoided clinical consequences(One year)
- Adherence evaluation with oral cancer targeted therapy by pill count(6 months after oral therapy initiation)
- Adherence evaluation with oral cancer targeted therapy by therapeutic drug monitoring(day 15, 30 and 6 months after oral therapy initiation)
- Clinical gradation of drug drug interactions(One year)
- Cost of the pharmacist intervention by avoided clinical consequence(One year)
- Adherence evaluation with oral cancer targeted therapy by the 6 item-Girerd Scale(day 15, 30 and 6 months after oral therapy initiation)