Before and After Study, Evaluating the Efficiency of an Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Duration of stay in day hospital unit
研究概览
简要总结
The present study proposes a new organization of the Day Hospital unit with several possible pathways defined by PRO.
The organization realies on a platform composed of nurses supervised by an IPA and a doctor one day before a treatment in the day hospitalization unit admission, results of PROs collectyed through the CEM@santé application (a French health care application) are reviewed by nurses from the platform and chemotherapy delivery is confirmed.
The study is planed in 2 steps.
- st stage: the current circuit remains unchanged (with systematic medical or nursing validation to confirm chemotherapy administration. Patient satisfaction is collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase.
- nd stage: a short circuit is set up. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation. Patient satisfaction is also collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 greater than 18 years
- •Patient treated for solid malignancy
- •Patient starting a new chemotherapy or immunotherapy protocol.
- •Patient receiving one of the following intravenous antineoplastic treatments in day hospital: Nivolumab(1), Pembrolizumab(1), Folfox(2), Folfirinox(2), Xelox Carboplatin, EC chemotherapy (Epirubicin/Cyclophosphamide)
- •Affiliated and beneficiary to a social security system
- •Informed and written consent
- •Note1: may be used in combination with tyrosine kinase inhibitors (TKIs) Note 2 :may be used in combination with bevacizumab, cetuximab or panitumumab
排除标准
- •Patient treated in neo-adjuvant situation for breast cancer
- •Does not have a connected device (smartphone, tablet or computer)
- •Does not have an internet connection
- •Difficulty in filling out a questionnaire
- •Protected adult or deprived of her liberty
- •Pregnant or lactating woman
研究组 & 干预措施
front phase
The current circuit remains unchanged (medical or nursing validation to confirm chemotherapy administration). Patient satisfaction is collected at each visit to the day hospital unit for chemotherapy.
干预措施: Standard follow up (Other)
Post Phase
A short circuit is set up. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation). Patient satisfaction is also collected at each visit to the day hospital unit for chemotherapy.
干预措施: short circuit (Other)
结局指标
主要结局
Duration of stay in day hospital unit
时间窗: Immediately after the chemotherapy
Assess the impact on the duration of stay of an anticipated personalization of the stay in HDJ based on a platform of analysis of the PROs collected the day before and the implementation of a short circuit
次要结局
- Health related patient quality of life(Immediately after the chemotherapy)
- Caregiver satisfaction(Month3;Month6)
- patient satisfaction(Immediately after the chemotherapy)