Shared Health Information System for Febrile Neutropenia (NEUTROSIS)

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

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).

Study Overview

• Status: Completed
• Conditions: Hematologic Neoplasms; Febrile Neutropenia; Solid Tumor
• Intervention / Treatment: Device: NEUTROSIS

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92140
    • Hôpital Antoine Béclère
  • Clamart, France, 92140
    • Hôpital d'instruction des armées de Percy
  • Le Kremlin-Bicêtre, France, 94275
    • Hôpital Bicêtre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NEUTROSIS Intervention Group; 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.	Device: NEUTROSIS; evaluate a shared health information system (NEUTROSIS) for home-hospital management of febrile neutropenia after anti-tumor chemotherapy
No Intervention: CONTROL Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
average length of hospital stay for febrile neutropenia	average length of hospital stay for febrile neutropenia	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospitalisation rate	hospitalisation rate	6 months
healthcare use rate	emergency department, general practitioner,	6 months
Use rate	patient use rate	6 months

Collaborators and Investigators

• Sponsor: Marie-Helene METZGER
• Collaborators: Assistance Publique - Hôpitaux de Paris; Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Francois BOUE, MD,PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Actual): October 20, 2019
• Study Completion (Actual): October 20, 2019

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: mHealth; febrile neutropenia; disease management; neutropenia/chemically induced/*complications; antineoplastic agents/*adverse events; Patient readmission
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Wounds and Injuries; Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Body Temperature Changes; Heat Stress Disorders; Hematologic Neoplasms; Neutropenia; Hyperthermia; Fever; Febrile Neutropenia
• Other Study ID Numbers: 16-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No