NCT04688762

Brief Summary

Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

December 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

1.9 years

First QC Date

December 24, 2020

Last Update Submit

December 20, 2022

Conditions

Keywords

empathy

Outcome Measures

Primary Outcomes (1)

  • Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.

    The average obtained in the CARE questionnaire by patients (score \[10-50\])

    before surgery

Study Arms (2)

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)

Interventions

A numeric application used as a support in consultation to explain the surgical management of the patient.

Group with the e-consult tool

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with breast cancer with surgery indication

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre François Baclesse

Caen, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2020

First Posted

December 30, 2020

Study Start

December 24, 2020

Primary Completion

November 16, 2022

Study Completion

November 16, 2022

Last Updated

December 21, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations