Implementation of a Therapeutic Educational Program Applicated to Adherence of Patients Treated by Capecitabine Alone or in Combination With Lapatinib
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- evaluation of the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib.
详细描述
200 subjects who meet the inclusion/exclusion criteria treated by capecitabine +/- lapatinib, will be enrolled into the study. Adherence to treatment of all subjects will be assessed during a first adherence evaluation period of 3 cycles in order to identify patients who need educational intervention(non adherent patients). Only nonadherent patients (adherence rate < 80%) will receive an education intervention. During the educational program, the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib will be evaluated for the 6 subsequent cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age> 18 years
- •histologically confirmed breast cancer or colorectal cancer
- •Patient starting oral treatment : capecitabine alone or in combination with lapatinib (can be included before the first cycle or during the first 2 cycles).
- •Volunteer to participate in the study.
- •ambulatory treated patient
- •Able to read, write and understand French.
- •Subject who accept to use MEMS monitors to automatically compile their drug dosing histories
- •Written informed consent
排除标准
- •more than 3 metastatic chemotherapies
- •any severe concomitant condition which makes it undesirable for the patient to participate in the study or which would jeopardize adherence with trial protocol
研究组 & 干预措施
capecitabine
patients treated by capecitabine alone (n=100)
干预措施: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib (Other)
capecitabine + lapatinib
patients treated by capecitabine and lapatinib (n=100)
干预措施: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib (Other)
结局指标
主要结局
evaluation of the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib
时间窗: every visit during 3 cycles i.e. 9 weeks (adherent patients) and for 6 additional cycles i.e. 18 weeks during educational intervention (nonadhererent patients)
the efficacy of the implementation of an educational program will be evaluated by adherence assessment using electronic monitoring system
次要结局
- patient satisfaction to the educational program as determined by questionnaire(at the end of the educational program i.e. approximately during the week 27)
- safety and tolerability as determined by adverse events frequency(for 3 cycles e.i. 9 weeks (adherent patients) or 9 cycles e.i. 27 weeks (nonadherent patients))