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Shared Health Information System for Febrile Neutropenia

Evaluation of a Shared Health Information System for Home-hospital Management of Febrile NEUTROpenia After Cytotoxic Chemotherapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03087227
Acronym
NEUTROSIS
Enrollment
121
Registered
2017-03-22
Start date
2017-02-22
Completion date
2019-10-20
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia, Hematologic Neoplasms, Solid Tumor

Keywords

mHealth, febrile neutropenia, neutropenia/chemically induced/*complications, antineoplastic agents/*adverse events, Patient readmission, disease management

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).

Interventions

DEVICENEUTROSIS

evaluate a shared health information system (NEUTROSIS) for home-hospital management of febrile neutropenia after anti-tumor chemotherapy

Sponsors

Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Marie-Helene METZGER
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
average length of hospital stay for febrile neutropenia6 monthsaverage length of hospital stay for febrile neutropenia

Secondary

MeasureTime frameDescription
hospitalisation rate6 monthshospitalisation rate
healthcare use rate6 monthsemergency department, general practitioner,
Use rate6 monthspatient use rate

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026