跳至主要内容
临床试验/NCT03289286
NCT03289286已完成不适用

Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer

Institut Claudius Regaud1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年11月17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
入组人数
40
试验地点
1
主要终点
Rate of patients without failure to the e-follow-up. A failure is defined by absence of connection to the electronic tool and the mismatch between the alert level and severity of complications.

研究概览

简要总结

This is a monocentric, prospective cohort study evaluating the feasibility of a perioperative e-follow-up protocol in patients with ambulatory surgery for breast cancer.

This protocol will be based on:

  • A coordinated ambulatory follow-up performed by a dedicated nurse
  • An electronic follow-up tool used in pre- and post-surgery

Patients will be followed 8 days before the surgery until 30 days after the surgery of breast cancer.

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
Female
接受健康志愿者
否

入选标准

  • •Patient eligible for an ambulatory surgery of breast cancer (partial mastectomy with or without lymph node sampling)
  • •Ambulatory surgery planned 10 days or more after inclusion date
  • •Age > or = 18 years old
  • •Affiliated to the french social security system
  • •Patient must provide written informed consent prior to any study-specific procedure or assessment

排除标准

  • •Surgery other than breast cancer surgery in ambulatory (benign breast surgery, other surgical specialities)
  • •Patient who cannot connect to the electronic tool at home (no computer, no tablet computer or no internet connection)
  • •Pregnant or breastfeeding women
  • •Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
  • •Patient protected by law

研究组 & 干预措施

Patients with breast cancer operated in ambulatory

Other

干预措施: Dedicated and coordinated e-follow-up. (Other)

结局指标

主要结局

Rate of patients without failure to the e-follow-up. A failure is defined by absence of connection to the electronic tool and the mismatch between the alert level and severity of complications.

时间窗: 1.5 months by patient

次要结局

  • Patient satisfaction to the e-follow-up.(1.5 months by patient)
  • The rate of patients who discontinue the study 8 days before the surgery.(1.5 months by patient)
  • Rate of patients with at least one unplanned visit.(1.5 months by patient)
  • The number of unplanned visits into the Center after ambulatory surgery in the first 24 hours and during the first 30 days will be assessed for each patient.(1.5 months by patient)
  • The time spent by the dedicated nurse for the follow-up protocol management.(1.5 months by patient)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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