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

Institut Claudius Regaud

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Dedicated and coordinated e-follow-up.

Study type: Interventional

Funder types: Other

Identifiers

NCT03289286

17SEIN04

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Patients with breast cancer operated in ambulatory

Other group

Treatment:

Other: Dedicated and coordinated e-follow-up.