Shared Health Information System for Febrile Neutropenia

NCT ID: NCT03087227

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2019-10-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NEUTROSIS

Intervention Type: DEVICE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NEUTROSIS

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Marie-Helene METZGER

OTHER

Sponsor Role: lead

Responsible Party

Marie-Helene METZGER

Dr

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Francois BOUE, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Antoine Béclère

Clamart, , France

Hôpital d'instruction des Armées de Percy

Clamart, , France

Hôpital BICETRE

Le Kremlin-Bicêtre, , France

Countries

France

Other Identifiers

16-009

Identifier Type: -

Identifier Source: org_study_id