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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03289286
Acronym
PITCA
Enrollment
40
Registered
2017-09-20
Start date
2017-11-17
Completion date
2018-06-29
Last updated
2018-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Ambulatory surgery, Electronic tool, e-follow-up

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.

Interventions

OTHERDedicated and coordinated e-follow-up.

In pre- and post-surgery: * Completion of questionnaires using an electronic tool, * Telephone follow-up if necessary between the nurse and the patient.

Sponsors

Institut Claudius Regaud
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frameDescription
Patient satisfaction to the e-follow-up.1.5 months by patientSatisfaction will be evaluated by questionnaire.
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.1.5 months by patientIt 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026