Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Région Nouvelle Aquitaine | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients treated for an advanced metastasis breast cancer
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nathalie QUENEL-TUEUX, MD | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonie | Bordeaux | 33076 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Advanced Disease | Patients treated for an advanced metastasis breast cancer |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Advanced Disease | Patients treated for an advanced metastasis breast cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients alive, not lost to follow-up, and with a completed questionnaire | Posted | Median | Full Range | score on a scale | 12 months |
|
|
12 months. Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Advanced Disease | Patients treated for an advanced metastasis breast cancer |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Pélissier, Director of Clinical Trials | Institut Bergonié | +33556333333 | s.mathoulin@bordeaux.unicancer.fr |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 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. | Patients alive, not lost to follow-up, and with a completed questionnaire | Posted | Median | Full Range | score on a scale | 6 months |
|
|
|
| 3 |
| 15 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |