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

Last updated: April 26, 2024
Sponsor: Institut de cancérologie Strasbourg Europe
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Urologic Cancer

Prostate Cancer

Treatment

CONTINUUM+ CONNECT remote monitoring

Clinical Study ID

NCT06379880
2023-031
2024-A00120-47
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patients aged ≥ 18 years with a solid tumor (only breast, lung, colorectal,prostate cancer) at the metastatic stage followed on an outpatient basis;
  2. Patients initiating oral and/or injectable anticancer treatment, whatever the line oftreatment, administered on an outpatient basis including day hospitalization;
  3. Patients who have given their written, free and informed consent;
  4. Patients with life expectancy of more than 3 months;
  5. Patients able to complete questionnaires according to the investigator's judgment, andto use the CONTINUUM+ CONNECT electronic application either alone or accompanied by aprofessional (home nurse);
  6. Patients affiliated to a social security scheme or beneficiaries of such a scheme.

Exclusion

Exclusion Criteria:

  1. Patients receiving home hospitalization care or being hospitalized at the time oftreatment initiation;
  2. Patients receiving concomitant radiotherapy;
  3. Patients using another remote monitoring application;
  4. Patients enrolled in another clinical trial;
  5. Patients protected by law.

Study Design

Total Participants: 506
Treatment Group(s): 1
Primary Treatment: CONTINUUM+ CONNECT remote monitoring
Phase:
Study Start date:
April 25, 2024
Estimated Completion Date:
February 25, 2025

Study 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.

Connect with a study center

  • Sainte-Catherine, Institut du Cancer Avignon-Provence

    Avignon, 84918
    France

    Site Not Available

  • Plyclinique de Blois

    Blois, 41260
    France

    Site Not Available

  • Polyclinique de Blois

    Blois, 41260
    France

    Site Not Available

  • Pôle Santé République

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • centre Georges François Leclerc

    Dijon, 21079
    France

    Site Not Available

  • Chu Dupuytren

    Limoges, 87042
    France

    Site Not Available

  • Centre d'oncologie de Gentilly

    Nancy, 54100
    France

    Active - Recruiting

  • Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA

    Plérin, 22190
    France

    Site Not Available

  • Institut Jean Godinot

    Reims, 51100
    France

    Active - Recruiting

  • CHU de Saint-Etienne

    Saint-Priest-en-Jarez, 42270
    France

    Site Not Available

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091
    France

    Site Not Available

  • Institut de cancérologie Strasbourg Europe

    Strasbourg, 67033
    France

    Active - Recruiting

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