Impact of the Nurse Visit on Observance of the Intake of Oral Carcinological Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 12
- 主要终点
- Comparison, at 3 months after the oncological treatments began, of the observance rate of the anticancer drugs (corresponding to the entire carcinological protocol) with or without passage of a nurse at the patient's home.
研究概览
简要总结
The increasingly used oral anticancer treatments allow the patient to reduce treatment and social constraints to reduce hospitalization costs. The counterpart is a decrease in the monitoring of the correct intake of drugs and the detection of side effects. These two risks are major in the elderly, due to comorbidities, poly-medication and decreased attention. The project objective to evaluate the impact of a bi-weekly nursing visit to the patients' homes for 3 months, compared to a conventional management without a nursing visit. It is a prospective, randomized, controlled, multicenter study to include 224 patients over 18 months. The impact will be assessed by counting the tablets not taken and by filling an observation booklet with the nurse at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 70 and over
- •Patient initiating an oral anticancer treatment (Chemotherapy, Targeted therapy, 2nd generation hormone therapy type Acetate abiraterone and Enzalutamide)
- •Patient who received an onco-geriatric assessment
- •Patient with informed consent signed
排除标准
- •Patient in a medical institution
- •Patient under exclusive hormone therapy
- •Patient already eligible for nurse support
- •Patient not speaking French
- •Patient under tutelage and guardianship or under safeguard of justice
- •Patient already included in a research protocol
- •Patient sharing his or her home with a person receiving nursing care at home more than once a week and for a period longer than 1 month after the patient's inclusion.
结局指标
主要结局
Comparison, at 3 months after the oncological treatments began, of the observance rate of the anticancer drugs (corresponding to the entire carcinological protocol) with or without passage of a nurse at the patient's home.
时间窗: 3 months
次要结局
- Comparison of the patient's perception of observance to anticancer therapy(3 months)
- Assessment of patients' satisfaction (of the arm with passage of the nurse) and the professionals(3 months)
- Comparison of causes of possible premature and definitive cessation of cancer treatments 3 months after the start of treatment and changes in treatment (dose, rhythm of cycles)(3 months)
- Determination of the percentage of patients able to be included in the study compared to the number of patients who received an oncogeriatric assessment(3 months)