NCT04008056已完成不适用
Impact of Patient Reported Outcomes for Pre-chemotherapy Medical Decision in Day Patients With Digestive Cancer
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2019年11月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Authorization for preparation of chemotherapy based on clinical information (decision 2)
研究概览
简要总结
The investigators hypothesize that an early assessment of the clinical toxicity of the patient is possible via patient reported outcomes and that this information provides at least the same information level as the clinical examination of the patient made by the doctor. The early decision to prepare chemotherapy medications based on the indirect early collection of clinical information from the patient via a patient reported outcome should help minimize the number of chemotherapy medications destroyed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •Patient is undergoing at least their second chemotherapy regime (outside weekly scheme or protocol with cisplatin requiring hospitalization) for a digestive tumor
- •Patient has a Smartphone or access to the internet (via tablet or computer)
- •The patient is under consultation as a day patient in the Oncology Department of Nimes hosptial
排除标准
- •The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •The patient is pregnant, parturient or breastfeeding
- •Patient has already participated in the study
- •Patient undergoing first chemotherapy regime
结局指标
主要结局
Authorization for preparation of chemotherapy based on clinical information (decision 2)
时间窗: Day 1
Yes/no
Authorization for preparation of chemotherapy based on patient reported outcome (decision 3)
时间窗: Day 1
Yes/no
次要结局
- Cost of unused pouches of prepared chemotherapy according to decisions(Day 1)
- Authorization for preparation of chemotherapy based on biological results (decision 1)(Day 0)
- Patient satisfaction with the patient reported outcome questionnaire(Before starting chemotherapy (Up to 72 hours prior to treatment starting))
研究者
研究点 (2)
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