Clinical trial NCT03087227: Shared Health Information System for Febrile Neutropenia
Official title: Evaluation of a Shared Health Information System for Home-hospital Management of Febrile NEUTROpenia After Cytotoxic Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Febrile Neutropenia
Solid Tumor
Hematologic Neoplasms
Keywords: mHealth
febrile neutropenia
neutropenia/chemically induced/*complications
antineoplastic agents/*adverse events
Patient readmission
disease management
Lead sponsor: University of Paris 13
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-03-22
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Age\> 18 years
* Patient receiving cytotoxic chemotherapy for solid tumor or hematological malignancy
* Patient having signed consent to participate in the study
* Patient able to understand the protocol of care
* Patient covered by health insurance
* Patient with the use of a smartphone or tablet with Internet connection

Exclusion Criteria:

* patient refusing to participate in the study
* patient participating in a drug trial
* patient receiving or shifting to a weekly chemotherapy protocol

Primary outcomes:
measure: average length of hospital stay for febrile neutropenia
timeFrame: 6 months
Secondary outcomes:
measure: hospitalisation rate
timeFrame: 6 months
measure: healthcare use rate
timeFrame: 6 months
measure: Use rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Clamart
country: France
facility: Hôpital d'instruction des Armées de Percy
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital BICETRE
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Francois BOUE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: