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Completed

NCT Number: NCT03087227

Shared Health Information System for Febrile Neutropenia

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Antoine Béclère, Clamart, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NEUTROSIS

Device

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

Primary outcomes

  1. average length of hospital stay for febrile neutropenia

    Time frame: 6 months

    average length of hospital stay for febrile neutropenia

Secondary outcomes

  1. hospitalisation rate

    Time frame: 6 months

    hospitalisation rate

  2. healthcare use rate

    Time frame: 6 months

    emergency department, general practitioner,

  3. Use rate

    Time frame: 6 months

    patient use rate

Sponsors and collaborators

Lead sponsor

Marie-Helene METZGER

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

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

Acronym: NEUTROSIS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2017
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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