Evaluation of the Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Number of early or unforeseen recourses to hospital for adverse event.
研究概览
简要总结
The purpose is to estimate evolution of patients treated by oral neoplastic agents, in term of early or unforeseen recourse to the hospital for adverse events.
详细描述
Introduction :
Oral antineoplastic agents know a full development in particular targeted therapies. Their adverse events (AE) lately detected can lead to non compliance or treatment discontinuation which can be at the origin of disease progression. They can also lead to hospitalization or recourse to emergency department associating to cost for the society.
Hypothesis :
A coordinated intervention of cancer network in relation with primary healthcare professionals, would improve safety of care's patient treated with oral antineoplastic agent by preventing serious AEs through rapid detection.
Primary objective :
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •patients affected by cancer (breast, colorectal, liver, lung, kidney, gastrointestinal stromal tumor, pancreas)
- •treated by capecitabine, erlotinib, gefitinib, imatinib, lapatinib, sorafenib, sunitinib, vinorelbine, Evérolimus, Pazopanib, Etoposide, Topotécan
- •18 years old or more
排除标准
- •refusal to participate
- •lack proficiency in French ,
- •having a Performance Status > 2,
- •home based care,
- •patient enrolled in clinical trials
- •patient enrolled in therapeutic education program
- •patient under administrative supervision or legal guardianship
- •not affiliated with Patient Social Security or CMU (recipient or beneficiary)
结局指标
主要结局
Number of early or unforeseen recourses to hospital for adverse event.
时间窗: within the first 6 monts after oral neoplastic agent introduction
次要结局
- number of hospitalization for AE(within the first 6 monts after oral neoplastic agent introduction)
- number of consultation for AE(within the first 6 monts after oral neoplastic agent introduction)
- quality of life(within the first 6 monts after oral neoplastic agent introduction)
- number of recourses to the health care system(within the first 6 monts after oral neoplastic agent introduction)
- number of AE per detection grade, AE maximal grade, AE all grade(within the first 6 monts after oral neoplastic agent introduction)
- all deaths and deaths from AE(within the first 6 monts after oral neoplastic agent introduction)
- medical economic evaluation(within the first 6 monts after oral neoplastic agent introduction)
- disease progression(within the first 6 monts after oral neoplastic agent introduction)
- drug dose-intensity taken by the patient during his treatment(within the first 6 monts after oral neoplastic agent introduction)
- number of early or unforeseen recourses to hospital for grade 1 / 2 AE(within the first 6 monts after oral neoplastic agent introduction)
- patient's satisfaction(within the first 6 monts after oral neoplastic agent introduction)