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

NCT06379880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2026-02-04

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Continuum Plus Santé

    collaborator UNKNOWN

  • Plateforme nationale qualité de vie et cancer

    collaborator UNKNOWN

  • WeShare

    collaborator UNKNOWN

  • Centre Paul Strauss

    lead OTHER

Principal Investigators

  • Philippe BARTHELEMY, MD · Hôpitaux Universitaires de Strasbourg

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-25
Primary Completion
2025-11-07
Completion
2026-01-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06379880 on ClinicalTrials.gov