Shared Health Information System for Febrile Neutropenia

Solid Tumor Clinical Trial

— NEUTROSIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087227
• Other study ID #: 16-009
• Status: Completed
• Phase: N/A
• Start date: February 22, 2017
• Est. completion date: October 20, 2019

Study information

• Verified date: May 2022
• Source: University of Paris 13
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 20, 2019
• Est. primary completion date: October 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Hematologic Neoplasms
• Hyperthermia
• Neutropenia
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Antoine Béclère	Clamart
France	Hôpital d'instruction des Armées de Percy	Clamart
France	Hôpital BICETRE	Le Kremlin-Bicêtre

Sponsors (3)

Lead Sponsor	Collaborator
Marie-Helene METZGER	Assistance Publique - Hôpitaux de Paris, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average length of hospital stay for febrile neutropenia	average length of hospital stay for febrile neutropenia	6 months
Secondary	hospitalisation rate	hospitalisation rate	6 months
Secondary	healthcare use rate	emergency department, general practitioner,	6 months
Secondary	Use rate	patient use rate	6 months