Evaluation of Efficiency in Cancerology of New Technologies as Telemedicine and Conected Objects (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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut Bergonie

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Quality of Life of the Patients at 12 Months

Time frame: 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.
Quality of Life of the Patients at 6 Months

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

Région Nouvelle Aquitaine

Registry information

Acronym: e-DomSanté

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Dec 2, 2017
Registry last updated: Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed