Breast Cancer
Conditions
Keywords
Telemedicine, Connected watches, Patient-Reported symptom monitoring, Secure Platform
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.
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.
Interventions
OTHERConected objects
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.
Sponsors
Région Nouvelle Aquitaine
Institut Bergonié
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life of the Patients at 12 Months | 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 | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Advanced Disease Patients treated for an advanced metastasis breast cancer | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Patients With Advanced Disease |
|---|---|
| Age, Continuous | 65 years |
| Region of Enrollment France | 15 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 15 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 12 months
Population: Patients alive, not lost to follow-up, and with a completed questionnaire
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With Advanced Disease | Quality of Life of the Patients at 12 Months | 59 score on a scale |
Primary
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.
Time frame: 6 months
Population: Patients alive, not lost to follow-up, and with a completed questionnaire
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With Advanced Disease | Quality of Life of the Patients at 6 Months | 58 score on a scale |