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

Breast Cancer Clinical Trial

— PITCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289286
• Other study ID #: 17SEIN04
• Status: Completed
• Phase: N/A
• Start date: November 17, 2017
• Est. completion date: June 29, 2018

Study information

• Verified date: August 2018
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Dedicated 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.

Locations

Country	Name	City	State
France	Institut Claudius Regaud IUCT-ONCOPOLE	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient satisfaction to the e-follow-up.	Satisfaction will be evaluated by questionnaire.	1.5 months by patient
Secondary	The rate of patients who discontinue the study 8 days before the surgery.		1.5 months by patient
Secondary	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
Secondary	Rate of patients with at least one unplanned visit.		1.5 months by patient
Secondary	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