Observational Study to Assess Adherence of Oral Anticancer Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Compliance with treatment
研究概览
简要总结
Oral anticancer treatments are increasingly numerous. They represent an additional alternative in the therapeutic arsenal of the clinician, and appear to satisfy patients who prefer this route of administration over intravenous treatment. The objective of oral therapies is twofold: to remove the constraints and risks associated with infusions and to allow the patient to follow his treatment at home.
However, they have significant adverse effects that may affect patients, who are sometimes at a disadvantage compared to how they are treated, and potentially lead to non-compliance with the consequences.
This study will identify the factors associated with non-adherence and determine the impact of this non-adherence in terms of treatment efficacy and tolerance.
The aim of this routine care study is to evaluate the adherence to oral anticancer therapies during 3 months.
详细描述
Primary objective
- To evaluate adherence to oral anti-cancer therapies at 3 months
Secondary objectives
- To evaluate the adherence to 3 months according to the age of the patients (less than 75 years versus 75 years and more)
- Evaluate compliance at 1 and 2 months
- Evaluate toxicity at 1, 2 and 3 months according to compliance according to criteria CTCAE 4.03.
- Evaluate response to treatment at 3 months based on adherence
- Evaluate the factors associated with adherence and describe the reasons for non-adherence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Age> 18 years
- •Cancer proved histologically.
- •Patient receiving an initial prescription for oral anticancer therapy, excluding hormone therapy
- •Illness measurable or assessable by imaging
- •Patient affiliated to a social security scheme
- •Patient having been informed of the study
- •Non-opposition of the patient
排除标准
- •Contraindication to oral treatment
- •Patient's refusal
- •Patient under tutelage, curatorship or safeguard of justice
- •Psychiatric illness and / or condition of the patient compromising understanding of information or conduct of the study
结局指标
主要结局
Compliance with treatment
时间窗: 3 months
Treatment adherence will be assessed by the number of treatment units taken in relation to the prescribed amount. A patient will be considered as observing if he has received at least 80% of the dose initially prescribed.
次要结局
- Toxicity(3 months)
- Response to treatment(3 months)