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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UNICANCER
- 入组人数
- 472
- 试验地点
- 67
- 主要终点
- Hospitalization-free survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ≤
- •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.
排除标准
- •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.
结局指标
主要结局
Hospitalization-free survival
时间窗: From randomization to death from any cause, up to 24 months
Hospitalization-free survival is the length of time from randomization during which patients enrolled in the study are not hospitalized and remain alive.
Overall survival
时间窗: From randomization to death from any cause, up to 24 months after last inclusion
overall survival is the length of time from randomization during which patients enrolled in the study remain alive.
Time to definitive Health-Related Quality of life score Deterioration
时间窗: At baseline then every 3 months, up to 24 months
The time to definitive Health-Related Quality of life score Deterioration is the length of time from randomization to the first deterioration of ≥ 10 points out of 100 or ≥2 points out of 14 in the global health status (GHS) score (items 29 and 30 of the QLQ-C30) compared with the baseline, assuming no improvement of at least 2 points in the GHS score compared with the baseline has occurred. The responses to the items 29-30 of the QLQ-C30 will be scored using the QLQ scoring manual. These 2 items have possible values ranging from 1 (very bad) to 7 (excellent) corresponding to a sum from 2 to 14 points. After conversion to percentages, the GHS will range from 0% to 100%. The higher the value, the better the quality of life.
次要结局
- Time-to-treatment failure(From randomization to treatment discontinuation, up to 24 months)
- Time to clinical deterioration(From randomization, to the date of the first clinical deterioration, up to 24 months)
- Socio-economic impact of digital telemonitoring(Throughout study completion, up to 24 months after randomization)
- Treatment compliance and extent of exposure(Throughout study completion, up to 24 months)
- Compliance with the use of Cureety digital telemonitoring(Throughout study completion, up to 24 months)
- Number of treatment lines(Throughout study completion, up to 24 months)
- Quality of Life Questionnaire - Breast cancer module (QLQ-BR45)(At baseline then every 3 weeks, up to 24 months)
- Patient's global satisfaction with care using the data of the EORTC OUT-PATSAT-35(6 months after randomisation)
- Toxicity-free survival(From randomization until the first event, up to 24 months)
- Quality of life questionnaire - Core 30 (QLQ-C30)(At baseline then every 3 weeks, up to 24 months)
- Satisfaction with Cureety telemonitoring(3 months after randomisation for the patients and 1 year after the site activation for medical team)
- Incidence of Adverse Events(Throughout study completion, up to 24 months)