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

NCT03289286 | Completed

• 1 other identifier: 17SEIN04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient satisfaction to the e-follow-up.

  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.

  1.5 months by patient

Study Arms (1)

Patients with breast cancer operated in ambulatory

OTHER

Other: Dedicated and coordinated e-follow-up.

Interventions

Dedicated and coordinated e-follow-up. OTHER

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

Patients with breast cancer operated in ambulatory

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient eligible for an ambulatory surgery of breast cancer (partial mastectomy with or without lymph node sampling)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut Claudius Regaud IUCT-ONCOPOLE

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dimitri GANGLOFF

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: November 17, 2017
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: August 6, 2018

Record last verified: 2018-08

Locations

FR (1)