Impact of Clinical Pharmacy Consultations in Patients With Cancer Treated With Oral Anti-cancer Therapies on the Rate of Serious Adverse Events
试验速览
- 阶段
- 不适用
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Rate of grade III-IV adverse events defined by the NCI criteria
研究概览
简要总结
The improvement of the care pathway of oncology patients through Clinical Pharmacy activities for outpatients (such as pharmaceutical consultation) should be implemented and evaluated.
In order to improve the care pathway of patients on anticancer oral therapies, The investigators suggest in this research project to integrate into the medical care a "Clinical Pharmacy follow-up" for the patient at the hospital in the form of "pharmaceutical consultations". These pharmaceutical consultations carried out in coordination with the hospital clinical teams also aim to make the link between the hospital and community pharmacists.
详细描述
The improvement of the care pathway of oncology patients through Clinical Pharmacy activities for outpatients (such as pharmaceutical consultation) should be implemented and evaluated.
In order to improve the care pathway of patients on anticancer oral therapies, the investigators suggest in this research project to integrate into the medical care a "Clinical Pharmacy follow-up" for the patient at the hospital in the form of "pharmaceutical consultations". These pharmaceutical consultations carried out in coordination with the hospital clinical teams also aim to make the link between the hospital and community pharmacists. These pharmaceutical consultations were initiated in Marseille and Grenoble University Hospitals in order to know the special needs of patients under oral chemotherapies. However, the impact of these pharmaceutical consultations in a population of patients receiving ambulatory oral therapy remains unknown and needs to be evaluated using objective criteria such as the rate of adverse events which the consequences are considerable both for the patient and the society.
These observations prompted us to establish a randomized controlled study with the objective of assessing the impact of the Clinical Pharmacy consultations in cancer patients treated with oral anti-cancer therapies on the general care management: occurrence of serious adverse events (primary outcome).
This bicenter, prospective, randomized, placebo-controlled, open-label, two-parallel group study is performed to assess the efficacy of pharmaceutical consultations in the experimental group (full clinical medication review) and pharmaceutical interviews in the control group (Patient Therapeutic Education for oral anticancer drugs only). Depending on the result of the randomization the patient will find himself in one of those 2 parallel arms:
- Control group: standard course + short pharmaceutical interviews (therapeutic education)
- Experimental group: standard course + long pharmaceutical consultations (including full clinical medication review and therapeutic education)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult patients over 18 years of both sexes
- •Patients with cancer pathology whatever stage/grade and associated comorbidities he has
- •Patients treated with oral cancer therapy for less than a month regardless of the therapy line
- •Have accepted to participate and signed the non-opposition form
排除标准
- •Patients less than 18 years of age and all vulnerable people, in accordance with French laws (pregnant women, adults under guardianship or trusteeship; persons deprived of liberty)
- •Patients under treatment for more than one month
- •Patients refusing to participate in the research project
结局指标
主要结局
Rate of grade III-IV adverse events defined by the NCI criteria
时间窗: 6 months
次要结局
- Drug adherence: Morisky scale 8-item;(1st, 3rd, 6th, 9th, 12th months of the study)
- The number of hospitalizations(1st, 3rd, 6th, 9th, 12th months of the study)
- Adverse events by the NCI criteria(1st, 3rd, 6th, 9th, 12th months of the study)
- Satisfaction toward the treatment: satisfaction with medicines questionnaire ((SatMed-Q®)(1st, 3rd, 6th, 9th, 12th months of the study)
- The number of visit to the emergency services(1st, 3rd, 6th, 9th, 12th months of the study)
- The number of additional medical consultations(1st, 3rd, 6th, 9th, 12th months of the study)
- Quality of life: Short Form 36 (SF-36) questionnaire(1st, 3rd, 6th, 9th, 12th months of the study)
- Survival: RECIST criteria(1st, 3rd, 6th, 9th, 12th months of the study)