Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Cureety techcare
DeviceEach 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.
Treatment groups
472 Participants
are divided into 2 treatment groupsGroup A: Telemonitoring groupExperimental treatment 1 intervention
Group B: Standard-of-care groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Time to definitive Health-Related Quality of life score Deterioration
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.
Time frame
At baseline then every 3 months, up to 24 months2
Hospitalization-free survival
Hospitalization-free survival is the length of time from randomization during which patients enrolled in the study are not hospitalized and remain alive.
Time frame
From randomization to death from any cause, up to 24 months3
Overall survival
overall survival is the length of time from randomization during which patients enrolled in the study remain alive.
Time frame
From randomization to death from any cause, up to 24 months after last inclusionSecondary outcomes
1
Time-to-treatment failure
Time-to-treatment failure is the time interval (in months) between the initiation of first-line chemotherapy and its premature discontinuation, irrespective of the reason for discontinuation.
Time frame
From randomization to treatment discontinuation, up to 24 months2
Toxicity-free survival
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the oncology research community as the leading rating scale for adverse events. This scale, divided into five grades (1 = "mild," 2 = "moderate," 3 = "severe," 4 = "life-threatening," and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders. Toxicity-free survival is defined as the time from randomization to the first event among a grade 3-4 non-hematological adverse event (graded using CTCAE version 5.0), a hospitalization for safety reasons, or death from any cause, whichever occurs first.
Time frame
From randomization until the first event, up to 24 months3
Time to clinical deterioration
-Time to clinical deterioration is defined by the time between randomization and deterioration of patient's level of functioning determined by the Eastern Cooperative Oncology Group (ECOG) performance status scale. The ECOG, widely accepted in the community of oncology research to assess how the disease affects the daily living abilities of the patient, is composed of 5 levels from grade 0 (fully active, able to carry on all pre-disease performance without restriction) to grade 5 (dead).
Time frame
From randomization, to the date of the first clinical deterioration, up to 24 months4
Number of treatment lines
Number of successive treatment lines offered to the patient from randomization to the end of the study.
Time frame
Throughout study completion, up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
UNICANCER
Lead sponsor
Cureety
Collaborator
Source ClinicalTrials.gov