Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment

Last updated: July 25, 2024
Sponsor: UNICANCER
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Cureety techcare

Clinical Study ID

NCT06505018
UC-BCG-2309
IDRCB NUMBER: 2023-A02477-38
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to assess whether adding telemonitoring (the digital telemonitoring platform "CUREETY TECHCARE"), to standard care, will benefit patients with previously untreated metastatic triple-negative breast cancer starting first-line cancer therapy.

The main questions it aims to answer are:

  • Is patient quality of life improved by using the telemonitoring platform?

  • Are patients hospitalized less frequently when using the telemonitoring platform?

  • Is the patient overall survival improved by telemonitoring ?

Researchers will compare data from patients using telemonitoring while receiving standard care with data from patients receiving only standard care.

Participants using telemonitoring will answer questions about their symptoms on the platform. The platform will analyze these symptoms, assess the patient's general condition and provide advice accordingly. Medical staff will also access the platform to monitor the patient's general condition and contact them if necessary.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed a written informed consent form prior to participate in the study. Note: Incase of physical incapacitation, a trusted representative of their choice, which isnot the Investigator or sponsor, can sign on the behalf of the patients

  • Patients ≥18 years of age.

  • Patient with histologically documented metastatic triple negative breast cancer (ER (Oestrogen receptor) and PR (Progesterone receptor) <10%, Her2 negative status).

  • Life expectancy > 6 months as per investigator estimate.

  • Patient initiating a marketed authorized first-line systemic treatment in themetastatic setting.

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.

  • Patient having completed the EORTC QLQ-C30 and EORTC QLQ-BR45 at baseline (responseto questions 29 and 30 of EORTC QLQ-C30 at baseline are mandatory)

  • Affiliated to the social security system or equivalent health insurance.

  • Patient able and willing to complete web-based self-reported questionnaires, frominitiation of first-line treatment and for the duration of the study (over multipletreatment lines)

  • Patient has access to a computer, tablet, or smartphone connected to the Internet.

Exclusion

Exclusion Criteria:

  • Participation in another clinical trial using telemonitoring.

  • Physical or psychological incapacity of the patient to use the digitaltelemonitoring Cureety Techcare, according to the investigator's discretion.

  • Patient deprived of their liberty or under protective custody or guardianship.

Study Design

Total Participants: 472
Treatment Group(s): 1
Primary Treatment: Cureety techcare
Phase:
Study Start date:
July 25, 2024
Estimated Completion Date:
September 02, 2027

Connect with a study center

  • Institut de Cancérologie des Hauts-de-France (ICHF)

    Arras,
    France

    Site Not Available

  • Centre Hospitalier d'Auxerre

    Auxerre,
    France

    Site Not Available

  • Sainte Catherine - Institut du Cancer Avignon Provence

    Avignon,
    France

    Active - Recruiting

  • CH Aunay-Bayeux

    Bayeux,
    France

    Site Not Available

  • Centre Hospitalier Simone Veil de Beauvais

    Beauvais,
    France

    Active - Recruiting

  • ICHF - Centre Pierre Curie

    Beuvry,
    France

    Site Not Available

  • Hôpital Simone Veil de Blois

    Blois,
    France

    Site Not Available

  • Polyclinique bordeaux nord

    Bordeaux,
    France

    Active - Recruiting

  • Centre Hospitalier Fleyriat

    Bourg-en-Bresse,
    France

    Site Not Available

  • Centre Francois Baclesse

    Caen,
    France

    Site Not Available

  • Centre de Cancérologie Privé de Caen Maurice Tubiana

    Caen,
    France

    Site Not Available

  • Centre hospitalier de Carcasonne

    Carcassonne,
    France

    Active - Recruiting

  • Recherche Oncologie Clinqiue 37 (ROC 37)

    Chambray-lès-Tours,
    France

    Site Not Available

  • CH de Cholet

    Cholet,
    France

    Active - Recruiting

  • CH Colmar

    Colmar,
    France

    Site Not Available

  • Groupe Hospitalier Public du Sud de l'Oise (GHPSO)

    Creil,
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon,
    France

    Site Not Available

  • Institut Andrée Dutreix

    Dunkerque,
    France

    Site Not Available

  • Centre Hospitalier Intercommunal de Fréjus Saint Raphael

    Fréjus,
    France

    Site Not Available

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble,
    France

    Site Not Available

  • Groupe Hospitalier de La Rochelle-Ré-Aunis

    La Rochelle,
    France

    Site Not Available

  • CHU de la réunion

    La Réunion,
    France

    Site Not Available

  • Clinique Sainte Clotilde

    La Réunion,
    France

    Site Not Available

  • CHU Grenoble Alpes

    La Tronche,
    France

    Site Not Available

  • Centre Hospitalier Louis Pasteur

    Le Coudray,
    France

    Site Not Available

  • Centre Hospitalier Le Mans

    Le Mans,
    France

    Site Not Available

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay,
    France

    Site Not Available

  • GHBS Lorient

    Lorient,
    France

    Site Not Available

  • Centre Leon Berard

    Lyon,
    France

    Site Not Available

  • Clinique de la Sauvegarde

    Lyon,
    France

    Site Not Available

  • Hôpital Privé Jean Mermoz

    Lyon,
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille,
    France

    Site Not Available

  • CHI de Mont-de-Marsan et du Pays des Sources

    Mont-de-Marsan,
    France

    Site Not Available

  • Centre de Cancérologie du Grand Montpellier

    Montpellier,
    France

    Site Not Available

  • Hôpital Privé du Confluent

    Nantes,
    France

    Site Not Available

  • Clinique Ambroise-Pare Hartmann

    Neuilly-sur-Seine,
    France

    Site Not Available

  • Hôpital Américain de PARIS

    Neuilly-sur-Seine,
    France

    Site Not Available

  • CHU de Nimes

    Nîmes,
    France

    Site Not Available

  • CHR Orleans

    Orléans,
    France

    Site Not Available

  • CHP Sainte-Marie

    Osny,
    France

    Site Not Available

  • Diaconesses Croix Saint-Simon Hospital Complex

    Paris,
    France

    Site Not Available

  • Centre hospitalier de Pau

    Pau,
    France

    Active - Recruiting

  • CARIO - Hopital Privé des Cotes d'Armor

    Plérin,
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers,
    France

    Site Not Available

  • Institut Godinot

    Reims,
    France

    Site Not Available

  • Clinique Mathilde - Les Hôpitaux Privés Rouennais

    Rouen,
    France

    Site Not Available

  • Hia Begin

    Saint-Mandé,
    France

    Site Not Available

  • CHU de Saint-Etienne

    Saint-Étienne,
    France

    Site Not Available

  • CHU de Tours

    Tours,
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy,
    France

    Site Not Available

  • CH Annecy Genevois

    Épagny,
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.