Clinical trial NCT03359759: Evaluation of Efficiency in Cancerology of New Technologies as Telemedicine and Conected Objects (e-DomSanté)
Official title: Evaluation of Efficiency in Cancerology of New Technologies as Telemedicine and Conected Objects (e-DomSanté)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Telemedicine
Connected watches
Patient-Reported symptom monitoring
Secure Platform
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Région Nouvelle Aquitaine
First posted: 2017-12-02
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for an advanced metastasis breast cancer

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 wtaches and patient-reported symptom monitoring.

Detailed description: 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: 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

Primary outcomes:
measure: Quality of life of the patients
timeFrame: 3 months
measure: Quality of life of the patients
timeFrame: 6 months
measure: Quality of life of the patients
timeFrame: 9 months
measure: Quality of life of the patients
timeFrame: 12 months
measure: Quality of life of the patients
timeFrame: 15 months
measure: Quality of life of the patients
timeFrame: 18 months
measure: Quality of life of the patients
timeFrame: 21 months
measure: Quality of life of the patients
timeFrame: 24 months
Secondary outcomes:
measure: How patients feel about the study
timeFrame: 3 months
measure: How patients feel about the study
timeFrame: 6 months
measure: How patients feel about the study
timeFrame: 9 months
measure: How patients feel about the study
timeFrame: 12 months
measure: How patients feel about the study
timeFrame: 15 months
measure: How patients feel about the study
timeFrame: 18 months
measure: How patients feel about the study
timeFrame: 21 months
measure: How patients feel about the study
timeFrame: 24 months
measure: Number of consultation via telemedicine
timeFrame: through study completion, an average of 24 months
measure: Quality of sound and image quality
timeFrame: through study completion, an average of 24 months
measure: Medical actions after telemedicine
timeFrame: through study completion, an average of 24 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
Study officials:
References: