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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Dedicated and coordinated e-follow-up.

• Registration Number: NCT03289286
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Study Start: 2017-11-17
• Primary Completion: 2018-06-29
• Study Completion: 2018-06-29
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-03
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with breast cancer operated in ambulatory	Dedicated and coordinated e-follow-up.	-

Primary Outcome Measures

Name	Time	Method
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.	1.5 months by patient

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction to the e-follow-up.	1.5 months by patient	Satisfaction will be evaluated by questionnaire.
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	It will be defined as the sum of the time spent at different stages: initial training of patients, tracking of the connections to the tool, tracking of the alerts and telephone contacts.

Trial Locations

Locations (1)

Institut Claudius Regaud IUCT-ONCOPOLE; 🇫🇷 Toulouse, France