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| Name | Class |
|---|---|
| Clairval Hospital | UNKNOWN |
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This study is to evaluate the efficacy of a mobile app for monitoring the quality of life of patients but also on detection delay of side effects and/or complications linked to the therapeutic management. This allow to adapt their care more quickly, through a prospective randomized study. The impact of this connected monitoring of patients' anxiety will also be evaluated in this study as well as the time taken by the medical team to manage alerts generated by this application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connected EORTC-C30 arm (quality of life questionnaires on pad, phone,...) | Experimental | The patients in this arm will have connected mobile app at home and they will regularly fill questionnaires. There are two different questionnaires : one with 14 questions about patient's quality of life and about the evolution of his surgical scar. One with 9 questions only about quality of life. They will also have meetings with physicians. |
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| No QoL online follow-up arm | Other | The patient haven't any questionnaires to fill at home. This is the normal management of the pathology. They only have different meeting with the specialist,as usual. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connected application arm | Device | patients have to respond different questionnaires about their quality of life on the mobile app. And follow-up visits with the physicians as usual |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the impact of the connected mobile monitoring application on the quality of life, at 6 months, of patients treated for an operated glioma. | The primary outcome measure is the difference in quality of life assessed by the QLQ-BN20 scale at 6 months, compared to inclusion. This scale is made up of 20 items which are grouped into 4 dimensions (future uncertainty, visual disorder, motor dysfunction, and communication deficit) and 7 isolated items. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-François oudet | Contact | 0683346567 | jf.oudet@ecten.eu | |
| Marie-Hélène barba | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique privée | Recruiting | Marseille | 13009 | France |
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| ID | Term |
|---|---|
| D000075782 | Cell Phone Use |
| D005911 | Gliosis |
| ID | Term |
|---|---|
| D003142 | Communication |
| D001519 | Behavior |
| D012919 | Social Behavior |
| D010335 | Pathologic Processes |
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| Unconnected arm | Device | Follow-up visits with the pysicians as usual |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |