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

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 months

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 months

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 months

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 months

Incidence of Adverse Events

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.

Time frame: Throughout study completion, up to 24 months

Quality of life questionnaire - Core 30 (QLQ-C30)

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.

Time frame: At baseline then every 3 weeks, up to 24 months

Quality of Life Questionnaire - Breast cancer module (QLQ-BR45)

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 frame: At baseline then every 3 weeks, up to 24 months

Treatment compliance and extent of exposure

The treatment compliance and extent of exposure will be assess using dose intensity, treatment delays and dose reductions.

Time frame: Throughout study completion, up to 24 months

Compliance with the use of Cureety digital telemonitoring

Compliance is measured by the frequency of patient responses to the Cureety telemonitoring questionnaires.

Time frame: Throughout study completion, up to 24 months

Satisfaction with Cureety telemonitoring

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.

Time frame: 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

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).

Time frame: 6 months after randomisation

Socio-economic impact of digital telemonitoring

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

Time frame: Throughout study completion, up to 24 months after randomization