Evaluation of the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment, in Their Quality of Life and Medico-economic Analysis of This Follow-up Program Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Efficacy : Proportion of patients for which there was a modification in their care through the nurse device
研究概览
简要总结
This study evaluate the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment, in their Quality of Life and Medico-economic Analysis of this Follow-up Program Device.
详细描述
This study is a monocentric prospective cohort study designed to monitor the care of patients undergoing an intra venous chemotherapy. Patients with a solid tumor (200 patients in total), starting a first cycle of intravenous chemotherapy with 21 days cycle will be included in this study. Patients will be followed all over the chemotherapy period through regular and defined telephone appointments carried out by a dedicated nurse. During phone call, a specific questionnaire will be used in order to retrieve data regarding patients toxicities, general care, quality of life, ...Actions taken following each phone call will also be documented (consultation, hospitalization, prescription,...). The main objective of this study is to evaluate the impact of this telephone follow-up program on the care of patients under chemotherapy treatment. In addition, a medico-economic analysis of this device compared with historical data from the national database SNIIRAM will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Patient with a solid tumor.
- •Patient starting a first cycle of chemotherapy (+ - targeted therapy).
- •Patient starting intravenous chemotherapy including 21-day cycles.
- •Patient ≥18 years old.
- •Patient affiliated to a social security system in France.
- •Patient who signed the informed consent before study inclusion and before any study specific procedure.
排除标准
- •Patient already included in another interventional biomedical research.
- •Patient who began intravenous chemotherapy.
- •Patient who must receive an oral chemotherapy.
- •Patient who must be treated with a weekly chemotherapy or with concomitant radiotherapy.
- •Patient unreachable by phone.
- •Patient with no caregiver who can answer the phone in his place.
- •Pregnant or breastfeeding women.
- •Any psychological condition, family, geographic or social not to comply with medical monitoring and / or procedures in the study protocol.
- •Patient protected by law.
研究组 & 干预措施
Solid tumors
Patients with solid tumor starting a intra venous chemotherapy with 21 days cycles.
干预措施: Telephone follow-up nursing device (Other)
结局指标
主要结局
Efficacy : Proportion of patients for which there was a modification in their care through the nurse device
时间窗: 24 months
次要结局
- Cost of the follow-up nursing device for the establishing(24 months)
- Medical costs(24 months)
- Safety according to the classification of the CTCAE (Common for Toxicity Criteria for Adverse effects) V4.0(24 months)
- Quality of life using the QLQ-C30 questionnaire and the Skindex®-16 questionnaire(24 months)