Clinical trial NCT03289286: Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer
Official title: Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Ambulatory surgery
Electronic tool
e-follow-up
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Surgery other than breast cancer surgery in ambulatory (benign breast surgery, other surgical specialities)
2. Patient who cannot connect to the electronic tool at home (no computer, no tablet computer or no internet connection)
3. Pregnant or breastfeeding women
4. 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
5. Patient protected by law

Primary outcomes:
measure: 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.
timeFrame: 1.5 months by patient
Secondary outcomes:
measure: Patient satisfaction to the e-follow-up.
timeFrame: 1.5 months by patient
measure: The rate of patients who discontinue the study 8 days before the surgery.
timeFrame: 1.5 months by patient
measure: 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.
timeFrame: 1.5 months by patient
measure: Rate of patients with at least one unplanned visit.
timeFrame: 1.5 months by patient
measure: The time spent by the dedicated nurse for the follow-up protocol management.
timeFrame: 1.5 months by patient
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Claudius Regaud IUCT-ONCOPOLE
Study officials:
affiliation: Institut Claudius Regaud
name: Dimitri GANGLOFF
role: PRINCIPAL_INVESTIGATOR
References: