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

NCT03359759 | Completed Results

• 1 other identifier: IB2016-eDOMSANTE
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Telemedicine; Connected watches; Patient-Reported symptom monitoring; Secure Platform

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Conected objects OTHER

Every week, each patient report her symptoms and answer ten questions on the i-PAD. The connected watch reports the performance status (activtiy and time spent in bed or sitting), and the falls. If nurses or doctors detect any problem, they ask the patient for a telemedicine to try to help her. During the same time, nurses or doctors send a message on a secure plateform to the local team (nurse, General Practitioner, and pharmacists) and they reserve a place for an hospitalization if necessary.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for an advanced metastasis breast cancer

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Bergonié: lead
• Région Nouvelle Aquitaine: collaborator

Study Sites (1)

Institut Bergonie

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Simone Mathoulin-Pélissier, Director of Clinical Trials
• Organization: Institut Bergonié

s.mathoulin@bordeaux.unicancer.fr

+33556333333

Study Officials

• Nathalie QUENEL-TUEUX, MD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 10, 2025
• Results First Posted: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)