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

Unicancer

Status: Enrolling

Conditions: Metastatic Triple-Negative Breast Carcinoma

Treatments: Device: Cureety techcare

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06505018

UC-BCG-2309

IDRCB NUMBER: 2023-A02477-38 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 472 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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472 participants in 2 patient groups

Telemonitoring group

Experimental group

Description:

Standard of care with digital telemonitoring "Cureety TechCare". The telemonitoring will comprise weekly adverse event (AE) evaluations and their analyses by the "Cureety TechCare".

Treatment:

Device: Cureety techcare

Standard-of-care group

No Intervention group