Pharmaceutical Intervention in the Coordinated Care Pathway for Cancer Patients Treated With Oral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 396
- 试验地点
- 13
- 主要终点
- Impact of the coordinated pharmaceutical path on the tolerance of oral therapies against cancer.
研究概览
简要总结
The rise of oral therapies in the management of cancers has considerably changed the patient care path. If the oral route is preferred by patients because it offers a better quality of life, it is not without impact for patients and the health professionals involved in their management in their care. Indeed, the use of the oral route shifts part of the responsibility for monitoring treatment towards the patient, thereby leading to compliance problems, drug interactions and the management of adverse effects.These risks can cause complications or compromise the effectiveness of treatment, and generate additional costs for the investigator's health system. The study proposes to involve Healthcare Facilities Pharmacist and the Dispensary Pharmacist with all other health professionals.First, the hospital pharmacist will operate before the initiation of an oral route to perform a clinical pharmaceutical analysis of drug prescriptions. Then after the primary prescription and finally during a follow-up consultation 3 months after the initiation of treatment. The hypothesis of the study is that the coordinated intervention of the hospital pharmacist and of the dispensary pharmacist would improve the tolerance of oral treatments by reducing the number of serious adverse effects found, as well as improve the, quality of life, patient and professional satisfaction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patient aged 18 years old or more
- •Having given his written consent to participate in the study
- •Patients with advanced or metastatic solid tumor or relapsed hematologic malignancy
- •With an initiation of oral therapy
- •Performance Status 0, 1 or 2
排除标准
- •Patient receiving ongoing intravenous (IV) or subcutaneous (SC) anticancer treatment
- •Patient receiving ongoing oral therapy
- •Patient receiving first-generation hormone therapy
- •Patient receiving ongoing a coordinated pharmaceutical path
- •Patient participating in a therapeutic education program including a pharmacist
- •Patient already included in an interventional clinical trial
- •Oral therapy with Temporary Authorisation
- •Patient in a health or medico-social institution
- •Patient protected, under guardianship or unable to give free and informed consent
- •Patient does not speak French
- •Patient unable to read French
- •Patient unable to undergo the medical monitoring of the trial for geographical, social or psychological reasons.
- •Patients 70 years old with cognitive disorders identified by the G-CODE
结局指标
主要结局
Impact of the coordinated pharmaceutical path on the tolerance of oral therapies against cancer.
时间窗: 6 months from the treatment initiation
The impact on tolerance will be measured by the proportion of patients with at least one grade 3 or 4 adverse event occurring / confirmed, linked to oral therapy, and confirmed by the oncologist.
次要结局
- Impact of the coordinated pharmaceutical path on unplanned hospitalizations related to the oral therapy(6 months from the treatment initiation)
- Detection of concerted treatment modifications between oncologist and pharmacist related to oral therapy(6 months from the treatment initiation)
- Impact of the coordinated pharmaceutical path on quality of life: EORTC QLQ-C30 questionnaire(Inclusion ; 1 month ; 3 months and 6 months from the treatment initiation)
- Impact of the coordinated pharmaceutical path on the drug related problems.(6 months from the treatment initiation)
- Impact of the coordinated pharmaceutical path on the number of grade 3 and 4 adverse events detected linked to oral therapy(6 months from the treatment initiation)
- Assessment of the link between hospital and city(Through study completion, an average of 42 months)
- Impact of the coordinated pharmaceutical path on adherence to the oral therapy(1 month ; 3 months and 6 months from the treatment initiation)
- Satisfaction of patients related to the coordinated pharmaceutical path: questionnaire(6 months from the treatment initiation)