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

Официальное название

A Randomized Phase III Study Comparing the Digital Telemonitoring Platform "CUREETY TECHCARE" to Usual Standard of Care in Patients With Triple Negative Metastatic Breast Cancer Initiating a First-line Systemic Treatment

Обзор

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.

Вмешательства

• Устройство Cureety techcare
  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

Первичные конечные точки

• Time to definitive Health-Related Quality of life score Deterioration [Срок оценки: At baseline then every 3 months, up to 24 months]
• Hospitalization-free survival [Срок оценки: From randomization to death from any cause, up to 24 months]
• Overall survival [Срок оценки: From randomization to death from any cause, up to 24 months after last inclusion]

Вторичные конечные точки (12)

• Time-to-treatment failure [Срок оценки: From randomization to treatment discontinuation, up to 24 months]
• Toxicity-free survival [Срок оценки: From randomization until the first event, up to 24 months]
• Time to clinical deterioration [Срок оценки: From randomization, to the date of the first clinical deterioration, up to 24 months]
• Number of treatment lines [Срок оценки: Throughout study completion, up to 24 months]
• Incidence of Adverse Events [Срок оценки: Throughout study completion, up to 24 months]
• Quality of life questionnaire - Core 30 (QLQ-C30) [Срок оценки: At baseline then every 3 weeks, up to 24 months]
• Quality of Life Questionnaire - Breast cancer module (QLQ-BR45) [Срок оценки: At baseline then every 3 weeks, up to 24 months]
• Treatment compliance and extent of exposure [Срок оценки: Throughout study completion, up to 24 months]
• Compliance with the use of Cureety digital telemonitoring [Срок оценки: Throughout study completion, up to 24 months]
• Satisfaction with Cureety telemonitoring [Срок оценки: 3 months after randomisation for the patients and 1 year after the site activation for medical team]
• Patient's global satisfaction with care using the data of the EORTC OUT-PATSAT-35 [Срок оценки: 6 months after randomisation]
• Socio-economic impact of digital telemonitoring [Срок оценки: Throughout study completion, up to 24 months after randomization]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 51 центр

• Institut de Cancérologie des Hauts-de-France (ICHF) — Arras
• Centre Hospitalier d'Auxerre — Auxerre
• Sainte Catherine - Institut du Cancer Avignon Provence — Avignon
• CH Aunay-Bayeux — Bayeux
• Centre Hospitalier Simone Veil de Beauvais — Beauvais
• ICHF - Centre Pierre Curie — Beuvry
• Hôpital Simone Veil de Blois — Blois
• Polyclinique bordeaux nord — Bordeaux
• … и ещё 43 центра

Идентификаторы

NCT: NCT06505018 · UC-BCG-2309 · IDRCB NUMBER: 2023-A02477-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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