Shared Health Information System for Febrile Neutropenia

NCT03087227 | Completed DMC

• 1 other identifier: 16-009
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 3

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).

Conditions

Febrile Neutropenia; Solid Tumor; Hematologic Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• average length of hospital stay for febrile neutropenia

  average length of hospital stay for febrile neutropenia

  6 months

Secondary Outcomes (3)

• hospitalisation rate

  6 months

• healthcare use rate

  6 months

• Use rate

  6 months

Study Arms (2)

NEUTROSIS Intervention Group

EXPERIMENTAL

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

CONTROL Group

NO INTERVENTION

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.

Interventions

NEUTROSIS DEVICE

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

NEUTROSIS Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Marie-Helene METZGER: lead
• Assistance Publique - Hôpitaux de Paris: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (3)

Hôpital Antoine Béclère

Clamart, 92140, France

Location

Hôpital d'instruction des Armées de Percy

Clamart, 92140, France

Location

Hôpital BICETRE

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Febrile Neutropenia; Hematologic Neoplasms; Neutropenia

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms

Study Officials

• Francois BOUE, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 22, 2017
• Study Start: February 22, 2017
• Primary Completion: October 20, 2019
• Study Completion: October 20, 2019
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)