NCT06379880

Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution

Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution: Prospective, Randomized, Multicenter Trial FEGALA

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 411 (actual)
• Sponsor: Centre Paul Strauss · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostatic Neoplasms
• Lung Neoplasms
• Breast Neoplasms
• Colorectal Neoplasms

Interventions

Type	Name	Description
DEVICE	CONTINUUM+ CONNECT remote monitoring	CONTINUUM+ CONNECT is a web platform, accessible via the internet, which contains the digital medical device (DMN) Continuum+ alert module. This is a medical software intended for the interpretation of clinical constants, symptoms, adverse events and pain, generating alerts with a view to improving the monitoring of patients undergoing anticancer treatment. The "Continuum+ Alert Module" version 1.0.0 dated 30 April 2021 is CE-marked and will be used in accordance with the manufacturer's instructions for use by patients in the experimental group.

Timeline

• Start date: 2024-04-25
• Primary completion: 2025-11-07
• Completion: 2026-01-26
• First posted: 2024-04-23
• Last updated: 2026-02-04

Locations

13 sites across 1 country: France