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Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution: Prospective, Randomized, Multicenter Trial FEGALA
FEGALA is a comparative, multicenter, randomized, prospective, open-label study comparing the results observed at 3 months (± 15 days) on the EORTC QLQ-C30 scale in a group of patients with metastatic cancer followed on an outpatient basis and benefiting from the CONTINUUM+ CONNECT solution (with or without nursing support at home) versus comparable patients benefiting from conventional monitoring.
CONTINUUM+ CONNECT is a platform, accessible from a computer, a smartphone or a tablet, allowing remote monitoring of cancer patients followed on an outpatient basis. The remotely monitored patient is invited to answer questionnaires (regarding adverse events, physiological constants and pain) at home. These questionnaires are either completed by the patient himself, if his condition allows it (self-assessment) or completed with the help of a professional on an outpatient basis (hetero-assessment). The data and alerts are transmitted in real time to the healthcare professionals in charge of the patient who analyze them and then determine the course of action to take. In order to evaluate the impact of remote monitoring by CONTINUUM+ CONNECT on the quality of life and health of patients with metastatic cancer, the present prospective randomized multicenter study will be carried out. Four main types of cancer will be studied: Breast, Lung, Colorectal and Prostate cancer.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, De, France
Sainte-Catherine, Institut du Cancer Avignon-Provence
Avignon, France
Polyclinique de Blois
Blois, France
Pôle Santé République
Clermont-Ferrand, France
centre Georges François Leclerc
Dijon, France
Chu Dupuytren
Limoges, France
Centre Hospitalier de Morlaix
Morlaix, France
Centre d'oncologie de Gentilly
Nancy, France
Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA
Plérin, France
Institut Jean Godinot
Reims, France
Start Date
April 25, 2024
Primary Completion Date
November 7, 2025
Completion Date
January 26, 2026
Last Updated
February 4, 2026
411
ACTUAL participants
CONTINUUM+ CONNECT remote monitoring
DEVICE
Lead Sponsor
Centre Paul Strauss
Collaborators
NCT07191730
NCT07225946
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06797635