Trial Title:
Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment
NCT ID:
NCT06505018
Condition:
Metastatic Triple-Negative Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Telemonitoring
Triple Negative Breast Cancer
Cureety
Adverse events
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Cureety techcare
Description:
Each week, patients complete a questionnaire via the Cureety platform, specifically
designed for the drug class or specific treatment being administered. Based on their
responses, the Cureety TechCare algorithm classifies patients into one of four risk
categories: "correct" (green), "compromised" (yellow), "state to be monitored" (orange),
or "critical state" (red). (Note: the color code is not visible to the patient).
The medical team uses the dashboard for daily patient monitoring and manages alerts
related to the "clinical classification" of the patient's condition. The physician in
charge of telemonitoring interprets the data, adjusts the treatment as needed, and
provides supportive care during standard care consultations. Patients are also notified
of alerts with tailored messages guiding them on the actions to take according to the
category determined by the device.
Arm group label:
Telemonitoring group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Signed a written informed consent form prior to participate in the study. Note: In
case of physical incapacitation, a trusted representative of their choice, which is
not 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 the
metastatic setting.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
- Patient having completed the EORTC QLQ-C30 and EORTC QLQ-BR45 at baseline (response
to 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, from
initiation of first-line treatment and for the duration of the study (over multiple
treatment lines)
- Patient has access to a computer, tablet, or smartphone connected to the Internet.
Exclusion Criteria:
- Participation in another clinical trial using telemonitoring.
- Physical or psychological incapacity of the patient to use the digital
telemonitoring Cureety Techcare, according to the investigator's discretion.
- Patient deprived of their liberty or under protective custody or guardianship.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut de Cancérologie des Hauts-de-France (ICHF)
Address:
City:
Arras
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier d'Auxerre
Address:
City:
Auxerre
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Sainte Catherine - Institut du Cancer Avignon Provence
Address:
City:
Avignon
Country:
France
Status:
Recruiting
Facility:
Name:
CH Aunay-Bayeux
Address:
City:
Bayeux
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier Simone Veil de Beauvais
Address:
City:
Beauvais
Country:
France
Status:
Recruiting
Facility:
Name:
ICHF - Centre Pierre Curie
Address:
City:
Beuvry
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hôpital Simone Veil de Blois
Address:
City:
Blois
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Polyclinique bordeaux nord
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Fleyriat
Address:
City:
Bourg-en-Bresse
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre de Cancérologie Privé de Caen Maurice Tubiana
Address:
City:
Caen
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Francois Baclesse
Address:
City:
Caen
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre hospitalier de Carcasonne
Address:
City:
Carcassonne
Country:
France
Status:
Recruiting
Facility:
Name:
Recherche Oncologie Clinqiue 37 (ROC 37)
Address:
City:
Chambray-lès-Tours
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CH de Cholet
Address:
City:
Cholet
Country:
France
Status:
Recruiting
Facility:
Name:
CH Colmar
Address:
City:
Colmar
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Groupe Hospitalier Public du Sud de l'Oise (GHPSO)
Address:
City:
Creil
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Georges François Leclerc
Address:
City:
Dijon
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Institut Andrée Dutreix
Address:
City:
Dunkerque
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier Intercommunal de Fréjus Saint Raphael
Address:
City:
Fréjus
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Groupe Hospitalier Mutualiste de Grenoble
Address:
City:
Grenoble
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Groupe Hospitalier de La Rochelle-Ré-Aunis
Address:
City:
La Rochelle
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHU de la réunion
Address:
City:
La Réunion
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Clinique Sainte Clotilde
Address:
City:
La Réunion
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHU Grenoble Alpes
Address:
City:
La Tronche
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier Louis Pasteur
Address:
City:
Le Coudray
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier Le Mans
Address:
City:
Le Mans
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier Emile Roux
Address:
City:
Le Puy-en-Velay
Country:
France
Status:
Not yet recruiting
Facility:
Name:
GHBS Lorient
Address:
City:
Lorient
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Clinique de la Sauvegarde
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hôpital Privé Jean Mermoz
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Institut Paoli Calmettes
Address:
City:
Marseille
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHI de Mont-de-Marsan et du Pays des Sources
Address:
City:
Mont-de-Marsan
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre de Cancérologie du Grand Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hôpital Privé du Confluent
Address:
City:
Nantes
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Clinique Ambroise-Pare Hartmann
Address:
City:
Neuilly-sur-Seine
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hôpital Américain de PARIS
Address:
City:
Neuilly-sur-Seine
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHU de Nimes
Address:
City:
Nîmes
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHR Orleans
Address:
City:
Orléans
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHP Sainte-Marie
Address:
City:
Osny
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Diaconesses Croix Saint-Simon Hospital Complex
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre hospitalier de Pau
Address:
City:
Pau
Country:
France
Status:
Recruiting
Facility:
Name:
CARIO - Hopital Privé des Cotes d'Armor
Address:
City:
Plérin
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHU de Poitiers
Address:
City:
Poitiers
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Institut Godinot
Address:
City:
Reims
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Clinique Mathilde - Les Hôpitaux Privés Rouennais
Address:
City:
Rouen
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hia Begin
Address:
City:
Saint-Mandé
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHU de Saint-Etienne
Address:
City:
Saint-Étienne
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHU de Tours
Address:
City:
Tours
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Institut de Cancérologie de Lorraine
Address:
City:
Vandœuvre-lès-Nancy
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CH Annecy Genevois
Address:
City:
Épagny
Country:
France
Status:
Not yet recruiting
Start date:
July 25, 2024
Completion date:
September 2, 2027
Lead sponsor:
Agency:
UNICANCER
Agency class:
Other
Collaborator:
Agency:
Cureety
Agency class:
Industry
Source:
UNICANCER
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06505018
