Metastatic Triple-Negative Breast Carcinoma
Conditions
Keywords
Telemonitoring, Triple Negative Breast Cancer, Cureety, Adverse events
Brief 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.
Interventions
DEVICECureety 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 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.
Sponsors
Cureety
UNICANCER
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to definitive Health-Related Quality of life score Deterioration | 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. |
| Hospitalization-free survival | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment lines | Throughout study completion, up to 24 months | Number of successive treatment lines offered to the patient from randomization to the end of the study. |
| Incidence of Adverse Events | Throughout study completion, up to 24 months | The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 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. |
| Quality of life questionnaire - Core 30 (QLQ-C30) | At baseline then every 3 weeks, up to 24 months | Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
| Quality of Life Questionnaire - Breast cancer module (QLQ-BR45) | At baseline then every 3 weeks, up to 24 months | This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30. The QLQ-BR45 incorporates nine multi-item scales to assess body image, sexual functioning, breast satisfaction, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All items are rated on a four-point Likert-type scale (1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much), and are linearly transformed to a 0-100 scale. Higher scores indicate more severe symptoms or problems for all items. |
| Time-to-treatment failure | From randomization to treatment discontinuation, up to 24 months | 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. |
| Compliance with the use of Cureety digital telemonitoring | Throughout study completion, up to 24 months | Compliance is measured by the frequency of patient responses to the Cureety telemonitoring questionnaires. |
| Satisfaction with Cureety telemonitoring | 3 months after randomisation for the patients and 1 year after the site activation for medical team | Satisfaction with Cureety telemonitoring is measured by the percentage of participants (patients and medical team \[including nurse, clinical research associate, and investigators\]) satisfied by the regular usage of the Cureety telemonitoring tool. |
| Patient's global satisfaction with care using the data of the EORTC OUT-PATSAT-35 | 6 months after randomisation | The OUT-PATSAT35 is a 35-item satisfaction with care questionnaire measuring cancer outpatients' perception of hospital doctors and nurses, as well as aspects of care organisation and services. Each item is rated from 1 to 5 (bad to excellent). |
| Socio-economic impact of digital telemonitoring | Throughout study completion, up to 24 months after randomization | Socio-economic impact of digital telemonitoring will be assessed using the number of days of hospitalization and the number of unscheduled hospitalizations and emergency consultations |
| Treatment compliance and extent of exposure | Throughout study completion, up to 24 months | The treatment compliance and extent of exposure will be assess using dose intensity, treatment delays and dose reductions. |
| Toxicity-free survival | From randomization until the first event, up to 24 months | 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 to clinical deterioration | From randomization, to the date of the first clinical deterioration, up to 24 months | -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). |
Countries
France
Contacts
Primary ContactAdeline POITOU
Backup ContactJérôme LEMONNIER, PhD
Outcome results
None listed