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临床试验/NCT02323555
NCT02323555已完成不适用

Optimize the Requirements and Preparations in Outpatient Chemotherapy

Centre Francois Baclesse1 个研究点 分布在 1 个国家目标入组 624 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
624
试验地点
1
主要终点
Patient profile for Optima

研究概览

简要总结

A prescription of injectable anticancer therapy requires the collection of medical data (interview and physical examination) and often allied (laboratory tests). This requirement is made on the day of the arrival of the patient to not prepare these treatments incorrectly.

After receiving the prescription of treatment, it will take about 1 hour to prepare for pharmacy and more in times of high activity, to provide the day hospital pockets treatment, incompressible time when the patient waits to have his treatment.

A process has been selected (Optima) to anticipate prescribing injectable cancer treatments and their manufacturing to reduce patient waiting times on the day of his coming François BaclesseCentre day hospital.

详细描述

Given the investigators daily activity evaluated patients received 65-70 day hospital, assessing the feasibility of the project with an internalized platform seems most relevant to completely control the process and costs.

This project will consist of anticipation paramedic telephone consultation followed by a medical prescription validation will trigger the production of chemotherapy prematurely before the coming of the patient.

The François Baclesse Center therefore supports the idea of an early day hospital, that is to say a prescription and production pockets of chemotherapy before the arrival of the patient in the service.

This project was named PROJECT OPTIMA for "Optimize requirements and preparations chemotherapy Ambulatory Medicine" with a paramedic telephone consultation.

So this ambitious project is the first experience of a French advance routine injectable anticancer therapies, all protocols combined in a Centre for the Fight against Cancer but also in a hospital reference competent oncology and chemotherapy and whose preparation process of chemotherapy administered by injection is fully internalized and centralized.

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

  • •Patient (e) old (e) 18 or more;
  • •Patient (e) reached (e) from cancer and candidate (s) to treatment with injectable anticancer preparations in day hospital
  • •solid cancerous disease for which chemotherapy is given intravenously;
  • •Patient (e) able to communicate with the investigator or his representative;
  • •Patient (e) Affiliate (e) a social security scheme;
  • •Mastery of the French language;
  • •Consent and signed.

排除标准

  • •Exclusive orallyanticancer treatment ;
  • •Primary brain tumors;
  • •Patient (e) dysphonic or having difficulty communicating orally;
  • •Patient (e) receiving intravenous chemotherapy as part of a research protocol;
  • •Patient (e) to receive chemotherapy whose stability is less than 24:00 (Temsirolimus)
  • •Pathologies hematologic malignancies
  • •Inability to undergo medical monitoring test for geographical, social or psychological reasons.
  • •Patient (e) under guardianship or unable to give informed consent;
  • •Patient (s) whose cognitive functions do not allow a telephone interview.
  • •Any medical or psychological condition associated that could compromise the patient's ability to participate in the study

研究组 & 干预措施

Paramedic telephone consultation

Experimental

Establishment of a paramedic telephone consultation to the doctor to record the "virtual" early prescription or non-injectable cancer treatment before the arrival of the patient (Feasibility Process Optima), without changing the current practice of prescribing and dispensing of these treatments on the day of the coming of the patient.

干预措施: Paramedic telephone consultation (Other)

结局指标

主要结局

Patient profile for Optima

时间窗: up to 21 weeks

Rate of discordance for each chemotherapy protocol between the Optima process and the current process. Define which protocols for injectable cancer treatment (chemotherapy and / or targeted therapy) and for which patient profiles, the Optima process can be used routinely.

次要结局

  • Satisfaction(up to 21 weeks)

研究者

发起方
Centre Francois Baclesse
申办方类型
Other
责任方
Sponsor

研究点 (1)

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