Breast Cancere-CONSULTNCT04688762
The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients.
An observational study of Breast Cancer and Surgery, run by Centre Francois Baclesse at 1 site in France.
Trial summary
Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Surgery
- What is being tested?
- e-consult application (tool)
- How many people
- 207 participants
- Where
- 1 siteFrance
- Study dates
- 24 Dec 2020to 16 Nov 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient with breast cancer with surgery indication
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.
- Conditions
- Breast Cancer, Surgery
- Being tested
- e-consult application (tool)
- Keywords
- empathy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-consult application (tool)Other
A numeric application used as a support in consultation to explain the surgical management of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Group without the e-consult tool | Patients who had a standard consultation, without e-consult tool | |
| 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. Receives: Other: e-consult application (tool) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CARE Questionnaire Scores After Surgery
The Consultation and Relational Empathy (CARE) Measure assesses patients' perceptions of clinician empathy during the consultation. The total score ranges from 10 to 50, with higher scores indicating greater perceived clinician empathy and a better patient-clinician relationship.
Measured: After surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start24 Dec 2020
- Primary completion16 Nov 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688762
- Sponsor's protocol ID
- 2020-A02045-34
- Acronym
- e-CONSULT
- Status last verified
- Jul 2026
- First submitted
- 24 Dec 2020
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients.
- ClinicalTrials.gov ID
- NCT04688762
- Acronym / sponsor ID
- e-CONSULT / 2020-A02045-34
- Conditions
- Breast Cancer, Surgery
- Keywords
- empathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group without the e-consult tool | – | –Patients who had a standard consultation, without e-consult tool |
| Group with the e-consult tool | – | Other: e-consult application (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with breast cancer with surgery indication
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-consult application (tool)A numeric application used as a support in consultation to explain the surgical management of the patient. | Other | Group with the e-consult tool |
Primary outcome
CARE Questionnaire Scores After Surgery
Time frame: After surgery
The Consultation and Relational Empathy (CARE) Measure assesses patients' perceptions of clinician empathy during the consultation. The total score ranges from 10 to 50, with higher scores indicating greater perceived clinician empathy and a better patient-clinician relationship.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Surgery, run by Centre Francois Baclesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CARE Questionnaire Scores After Surgery (time frame: After surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.