Evaluation of Efficiency in Cancerology of New Technologies as Telemedicine and Conected Objects (e-DomSanté) (e-DomSanté)

Observational study about patients treated for a metastasis breast cancer who live far from their comprehensive cancer center and followed by telemedicine, connected watches and patient-reported symptom monitoring.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Conected objects

Detailed Description

The effectiveness of remote follow-up of cancer patients through weekly medicalquestionnaires filled in on their smartphone has been reported in international studies. Thesestudies demonstrated an improvement in quality of life (QoL) and survival of several months. Thee-DomSanté study proposes the combined use of innovative technological tools for theimprovement of patient care

This study was carried out with patients followed-up for metastatic breast cancer who lived far from their treatment center. They were offered, in addition to their usual follow-up, weekly medical questionnaires on an interactive tablet and aconnected watch that registered their falls, bedtime and their general activity. All this data arrive on a secure portal. In the event of an alert, telemedicine is organized by remote consultation with exchange on a secure platform, in parallel, between the center's carers and the treating physician, nurse, pharmacist or the Territorial Support Unit. The evaluation criteria used include telemedicine and patients' quality of life questionnaires as well as their satisfaction with care.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonié

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated for an advanced metastasis breast cancer

Description

Inclusion Criteria:

• Women more than 18 years old
• Treated for an advanced metastasis breast cancer
• Who live far from their comprehensive cancer center in the Landes department

Exclusion Criteria:

• Women who are not able to understand the study because of psychiatric disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life of the Patients at 12 Months	QoL assessed using the score of the FACT-B questionnaire. The FACT-B (Functional Assessment of Cancer Therapy - Breast) is a quality of life questionnaire used primarily with breast cancer patients. It is a validated tool used in both clinical and research settings. Total score range: 0-148 A higher score indicates better quality of life.	12 months
Quality of Life of the Patients at 6 Months	QoL assessed using the score of the FACT-B questionnaire. The FACT-B (Functional Assessment of Cancer Therapy - Breast) is a quality of life questionnaire used primarily with breast cancer patients. It is a validated tool used in both clinical and research settings. Total score range: 0-148 A higher score indicates better quality of life.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
How patients feel about the study	General questionnary for satisfaction	3 months
How patients feel about the study	General questionnary for satisfaction	6 months
How patients feel about the study	General questionnary for satisfaction	9 months
How patients feel about the study	General questionnary for satisfaction	12 months
How patients feel about the study	General questionnary for satisfaction	15 months
How patients feel about the study	General questionnary for satisfaction	18 months
How patients feel about the study	General questionnary for satisfaction	21 months
How patients feel about the study	General questionnary for satisfaction	24 months
Number of consultation via telemedicine	CRF done for each consultation	through study completion, an average of 24 months
Quality of sound and image quality	CRF done for each consultation	through study completion, an average of 24 months
Medical actions after telemedicine	CRF done for each consultation	through study completion, an average of 24 months

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Collaborators: Région Nouvelle Aquitaine
• Investigators: Principal Investigator: Nathalie QUENEL-TUEUX, MD, Institut Bergonié

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Estimated): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Connected watches; Patient-Reported symptom monitoring; Secure Platform
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: IB2016-eDOMSANTE

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