search
Back to results

Shared Health Information System for Febrile Neutropenia (NEUTROSIS)

Primary Purpose

Febrile Neutropenia, Solid Tumor, Hematologic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NEUTROSIS
Sponsored by
Marie-Helene METZGER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Febrile Neutropenia focused on measuring mHealth, febrile neutropenia, neutropenia/chemically induced/*complications, antineoplastic agents/*adverse events, Patient readmission, disease management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Antoine Béclère
  • Hôpital d'instruction des Armées de Percy
  • Hôpital BICETRE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NEUTROSIS Intervention Group

CONTROL Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

average length of hospital stay for febrile neutropenia
average length of hospital stay for febrile neutropenia

Secondary Outcome Measures

hospitalisation rate
hospitalisation rate
healthcare use rate
emergency department, general practitioner,
Use rate
patient use rate

Full Information

First Posted
February 20, 2017
Last Updated
May 2, 2022
Sponsor
Marie-Helene METZGER
Collaborators
Assistance Publique - Hôpitaux de Paris, Institut National de la Santé Et de la Recherche Médicale, France
search

1. Study Identification

Unique Protocol Identification Number
NCT03087227
Brief Title
Shared Health Information System for Febrile Neutropenia
Acronym
NEUTROSIS
Official Title
Evaluation of a Shared Health Information System for Home-hospital Management of Febrile NEUTROpenia After Cytotoxic Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
October 20, 2019 (Actual)
Study Completion Date
October 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marie-Helene METZGER
Collaborators
Assistance Publique - Hôpitaux de Paris, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile Neutropenia, Solid Tumor, Hematologic Neoplasms
Keywords
mHealth, febrile neutropenia, neutropenia/chemically induced/*complications, antineoplastic agents/*adverse events, Patient readmission, disease management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NEUTROSIS Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NEUTROSIS
Intervention Description
evaluate a shared health information system (NEUTROSIS) for home-hospital management of febrile neutropenia after anti-tumor chemotherapy
Primary Outcome Measure Information:
Title
average length of hospital stay for febrile neutropenia
Description
average length of hospital stay for febrile neutropenia
Time Frame
6 months
Secondary Outcome Measure Information:
Title
hospitalisation rate
Description
hospitalisation rate
Time Frame
6 months
Title
healthcare use rate
Description
emergency department, general practitioner,
Time Frame
6 months
Title
Use rate
Description
patient use rate
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois BOUE, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Antoine Béclère
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hôpital d'instruction des Armées de Percy
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hôpital BICETRE
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Shared Health Information System for Febrile Neutropenia

We'll reach out to this number within 24 hrs