An Evaluation Study on the Performance of a Guided Clinical Pharmacy Consultation for Patients With Multiple Myeloma Following Their First Oral Anticancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Observance of treatment by patients following Revlimid - Dexamethazone protocol who had the benefit of the Guided Clinical Pharmacy Consultation
研究概览
简要总结
Nowadays, more and more patients are receiving anticancer treatment by mouth and oral chemotherapy is a challenge for our health system as patients become autonomous and responsible for following their oral anti-cancer treatment at home.
According to the French National Cancer Institute around 5.000 new cases of multiple myeloma (MM) are detected each year, and this figure is on the increase. It is more common in people aged over 70. The patterns of oral anticancer medication for multiple myeloma are complex and these patients do not always follow their treatment correctly. A clinical pharmaceutical consultation guide was designed to overcome this problem.Our hypothesis is that the guided consultation would minimize the rate of discrepancies observed compared with the usual, standard type of management.
The main objective is therefore to evaluate the performance of this guided consultation (interventional group) in comparison with a control group (standard management) for patients with multiple myeloma on their first cure of oral anticancer medication.
详细描述
Nowadays, more and more patients are receiving anticancer treatment by mouth. In this context, the development of oral chemotherapy represents a challenge to our health system as it means adapting the hospital's organization and making it safer to manage patients who are becoming autonomous and responsible for following their oral anti-cancer treatment at home.
According to the French National Cancer Institute, around 5,000 new cases of multiple myeloma (MM) are detected each year, and this figure is on the increase year by year. It is more common in people aged over 70. Patients treated have several risk factors for not respecting medication adherence such as age, polypharmacy related to the presence of other chronic pathologies, and associated comorbidities. Furthermore, the patterns of administering oral anticancer medication for multiple myeloma are complex.
In a previous study we designed a clinical pharmaceutical consultation guide with a view to improving patients' adherence to their oral anticancer treatment. This guide was designed and validated by a multidisciplinary workgroup to ensure that it was readable, understandable and easy to memorize for the patients being treated for multiple myeloma. The guide was designed so that the information given was reproducible from one patient to another, whoever the pharmacist might be, by standardizing the information given. Our hypothesis is that the guided consultation would make it possible to minimize the rate of discordance observed compared with the usual, standard type of management.
The main objective of this study is to evaluate the performance of the guided consultation (Intervention) by evaluating the rate of discrepancies observed compared with the theoretical therapeutic pattern prescribed, compared with a control group(standard management) for patients with multiple myeloma on their first cure of oral anticancer medication.
Secondary objectives are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients being treated for multiple myeloma receiving their first oral anticancer treatment.
- •All patients being treated for multiple myeloma by autologous peripheral stem cell graft following the Revlimid - Velcade - Dexamethazone protocol
- •All patients who cannot be treated for multiple myeloma by autologous peripheral stem cell graft and who are following the Revlimid - Dexamethazone protocol
- •All patients who have given written informed consent.
- •All patients who have signed the consent form.
- •All patients covered by a health insurance scheme
排除标准
- •All patients requiring help at home from a nurse for taking their oral treatment
- •All patients participating in another category 1 research project.
- •All patients in an exclusion period determined by another study.
- •All patients for whom it is impossible to give enlightened information.
- •All patients who are pregnant or breastfeeding
结局指标
主要结局
Observance of treatment by patients following Revlimid - Dexamethazone protocol who had the benefit of the Guided Clinical Pharmacy Consultation
时间窗: End of treatment. Day 28 +/- 5 days
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage.
Observance of treatment by patients following Revlimid - Dexamethazone protocol who did not have the benefit of the Guided Clinical Pharmacy Consultation
时间窗: End of treatment. Day 28 +/- 5 days
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage
Observance of treatment by patients following Revlimid - Velcade - Dexamethasone protocol who had the benefit of a Guided Clinical Pharmacy Consultation
时间窗: End of treatment. Day 21 +/- 5 days
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage.
Observance of treatment by patients following Revlimid - Velcade - Dexamethasone protocol who did not not have the benefit of a Guided Clinical Pharmacy Consultation
时间窗: End of treatment. Day 21 +/- 5 days
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage.
次要结局
- Results of the self-questionnaire for patients following the Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.(End of treatment. Day 21 +/- 5 days)
- Pill-count for patients following Revlimid - Velcade - Dexamethasone protocol who did not benefit from the guided clinical pharmacy consultation.(End of treatment. Day 21 +/- 5 days)
- Results of the self-questionnaire for patients following the Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation(End of treatment. Day 21 +/- 5 days)
- Results of the self-questionnaire for patients following the Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation(End of treatment. Day 28 +/- 5 days)
- System Usability Score for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.(End of treatment. Day 28 +/- 5 days)
- Pill-count for patients following Revlimid - Dexamethazone protocol who did not benefit from the guided clinical pharmacy consultation.(End of treatment. Day 28 +/- 5 days)
- Results of the self-questionnaire for patients following the Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation(End of treatment. Day 28 +/- 5 days)
- System Usability Score for patients following Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation.(End of treatment. Day 28 +/- 5 days)
- Pill-count for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.(End of treatment. Day 21 +/- 5 days)
- Pill-count for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.(End of treatment. Day 28 +/- 5 days)
- System Usability Score for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.(End of treatment. Day 21 +/- 5 days)
- System Usability Score for patients following Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation.(End of treatment. Day 21 +/- 5 days)
- Semi-directive interview for patients following Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation.(End of treatment. Day 28 +/- 5 days)
- Rate of discrepancies per item in patients on Revlimid - Dexamethazone protocol who did not benefit from the Guided Clinical Pharmacy Consultation(End of treatment. Day 28 +/- 5 days)
- Semi-directive interview for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.(End of treatment. Day 21 +/- 5 days)
- Semi-directive interview for patients following Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation.(End of treatment. Day 21 +/- 5 days)
- Semi-directive interview for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.(End of treatment. Day 28 +/- 5 days)
- Rate of discrepancies per item in patients on Revlimid - Velcade - Dexamethasone protocol who benefitted from the Guided Clinical Pharmacy Consultation(End of treatment. Day 21 +/- 5 days)
- Rate of discrepancies per item in patients on Revlimid - Velcade - Dexamethasone protocol who did not benefit from the Guided Clinical Pharmacy Consultation(End of treatment. Day 21 +/- 5 days)
- Rate of discrepancies per item in patients on Revlimid - Dexamethazone protocol who benefitted from the Guided Clinical Pharmacy Consultation(End of treatment. Day 28 +/- 5 days)