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| Name | Class |
|---|---|
| Assistance Publique - Hôpitaux de Paris | OTHER |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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The use of e-health in improving the quality of health services is a rapidly expanding research area, in particular its usefulness in patient management of the home-hospital care pathway. Febrile neutropenia is a serious and frequent complication of cytotoxic chemotherapy and better identification of low-risk patients who can be treated at home could be made possible by these technologies.
The objective of this study is to evaluate a shared health information system (NEUTROSIS) for home-hospital management of febrile neutropenia after anti-tumor chemotherapy. The study aims to compare the average length of hospital stay for febrile neutropenia among patients receiving NEUTROSIS and those receiving standard care
Materials and methods A shared information system (NEUTROSIS) has been developed to connect a smartphone web application for the patient to the existing shared medical record of the Paris Sud hospital group (AP-HP, France - 4D software).
The study consists of conducting a randomized controlled trial to compare a cohort of patients receiving cytotoxic chemotherapy for solid cancer or heamatological malignancies using the NEUTROSIS shared information system (n=100) and a cohort of patients followed by the hospital's standard care over a treatment period of six months (n=100). During the 15 days following each chemotherapy cycle, the 2 groups of patients must take their temperature daily. Both groups are trained like any patient under chemotherapy to contact the team in case of fever. The NEUTROSIS group captures daily its temperature and the occurrence of other symptoms on the smartphone application. This information is then transmitted instantly to the hospital care team who will be alerted in case of fever and will contact the patient. The control group will indicate these same data in a paper diary and will have to contact the health team in case of fever as done in the usual care.
The two groups of patients will be followed 6 months through a questionnaire asked to the patient at each hospital visit for chemotherapy cycle. The questionnaire collects information on the occurrence of symptoms and healthcare use between two chemotherapy cycles. A last follow-up questionnaire is asked by phone at the endpoint follow-up (6 months). The study will take place in two hospital sites of the Paris University hospital (A Béclère and Kremlin-Bicètre).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEUTROSIS Intervention Group | Experimental | The NEUTROSIS Intervention group captures daily its temperature and the occurrence of other symptoms on the smartphone application. This information is then transmitted instantly to the hospital care team through the NEUTROSIS shared information system. The medical oncologist will be alerted in case of fever and will contact the patient. |
|
| CONTROL Group | No Intervention | The control group will monitor daily its temperature and the occurrence of other symptoms on a paper surveillance diary and will have to contact the health team in case of fever as done in the usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEUTROSIS | Device | evaluate a shared health information system (NEUTROSIS) for home-hospital management of febrile neutropenia after anti-tumor chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| average length of hospital stay for febrile neutropenia | average length of hospital stay for febrile neutropenia | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| hospitalisation rate | hospitalisation rate | 6 months |
| healthcare use rate | emergency department, general practitioner, | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francois BOUE, MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Antoine Béclère | Clamart | 92140 | France | |||
| Hôpital d'instruction des Armées de Percy |
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| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D019337 | Hematologic Neoplasms |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| Use rate | patient use rate | 6 months |
| Clamart |
| 92140 |
| France |
| Hôpital BICETRE | Le Kremlin-Bicêtre | 94275 | France |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |