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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Dedicated and coordinated e-follow-up.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with breast cancer operated in ambulatory<br> | Other: Dedicated and coordinated e-follow-up.<br>* In pre- and post-surgery: Completion of questionnaires using an electronic tool, Telephone follow-up if necessary between the nurse and the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction to the e-follow-up. | Satisfaction will be evaluated by questionnaire. | 1.5 months by patient | 
| The rate of patients who discontinue the study 8 days before the surgery. |  | 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 | 
| Rate of patients with at least one unplanned visit. |  | 1.5 months by patient | 
| The time spent by the dedicated nurse for the follow-up protocol management. | 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. | 1.5 months by patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Ambulatory surgery, Electronic tool, e-follow-up