The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients. (e-CONSULT)

December 20, 2022 updated by: Centre Francois Baclesse
Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • Centre François Baclesse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patient with breast cancer with surgery indication

Description

Inclusion Criteria:

  • Patient > 18 years old
  • Patient referred for first consultation for surgery
  • Patient referred for a breast tumorectomy and axillary sentinel node
  • No patient opposition to participating in this study

Exclusion Criteria:

  • Non-surgical management
  • Management by any surgery other than breast tumorectomy and axillary sentinel node
  • Any associated medical, social or psychopathological condition that could compromise the patient's ability to participate in the study
  • Patient deprived of liberty or under guardianship
  • Person subject to legal protection or unable to express their consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group without the e-consult tool
standard consultation
Group with the e-consult tool
The e-consult tool is a digital application developed and designed by the Center François Baclesse, This tool is a consultation support to explain the surgical management of the patient.
Other: e-consult application (tool)
A numeric application used as a support in consultation to explain the surgical management of the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.
Time Frame: before surgery
The average obtained in the CARE questionnaire by patients (score [10-50])
before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2020

Primary Completion (Actual)

November 16, 2022

Study Completion (Actual)

November 16, 2022

Study Registration Dates

First Submitted

December 24, 2020

First Submitted That Met QC Criteria

December 24, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02045-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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