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

NCT ID: NCT03289286

Last Updated: 2018-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-17

Study Completion Date

2018-06-29

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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patients with breast cancer operated in ambulatory

Group Type OTHER

Dedicated and coordinated e-follow-up.

Intervention Type OTHER

In pre- and post-surgery:

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut Claudius Regaud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dimitri GANGLOFF

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud

Locations

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Institut Claudius Regaud IUCT-ONCOPOLE

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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17SEIN04

Identifier Type: -

Identifier Source: org_study_id

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