Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment
NCT Number: NCT06505018
Acronym: ALTERNATIVE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metastatic Triple-Negative Breast Carcinoma
Interventions: DEVICE: Cureety techcare
Sponsor: UNICANCER
Collaborators: Cureety
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 472
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-25
Completion Date: 2027-09-02
Locations: Institut de Cancérologie des Hauts-de-France (ICHF), Arras, France|Centre Hospitalier d'Auxerre, Auxerre, France|Sainte Catherine - Institut du Cancer Avignon Provence, Avignon, France|CH Aunay-Bayeux, Bayeux, France|Centre Hospitalier Simone Veil de Beauvais, Beauvais, France|ICHF - Centre Pierre Curie, Beuvry, France|Hôpital Simone Veil de Blois, Blois, France|Polyclinique bordeaux nord, Bordeaux, France|Centre Hospitalier Fleyriat, Bourg-en-Bresse, France|Centre de Cancérologie Privé de Caen Maurice Tubiana, Caen, France|Centre Francois Baclesse, Caen, France|Centre hospitalier de Carcasonne, Carcassonne, France|Recherche Oncologie Clinqiue 37 (ROC 37), Chambray-lès-Tours, France|CH de Cholet, Cholet, France|CH Colmar, Colmar, France|Groupe Hospitalier Public du Sud de l'Oise (GHPSO), Creil, France|Centre Georges François Leclerc, Dijon, France|Institut Andrée Dutreix, Dunkerque, France|Centre Hospitalier Intercommunal de Fréjus Saint Raphael, Fréjus, France|Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France|Groupe Hospitalier de La Rochelle-Ré-Aunis, La Rochelle, France|CHU de la réunion, La Réunion, France|Clinique Sainte Clotilde, La Réunion, France|CHU Grenoble Alpes, La Tronche, France|Centre Hospitalier Louis Pasteur, Le Coudray, France|Centre Hospitalier Le Mans, Le Mans, France|Centre Hospitalier Emile Roux, Le Puy-en-Velay, France|GHBS Lorient, Lorient, France|Centre Leon Berard, Lyon, France|Clinique de la Sauvegarde, Lyon, France|Hôpital Privé Jean Mermoz, Lyon, France|Institut Paoli Calmettes, Marseille, France|CHI de Mont-de-Marsan et du Pays des Sources, Mont-de-Marsan, France|Centre de Cancérologie du Grand Montpellier, Montpellier, France|Hôpital Privé du Confluent, Nantes, France|Clinique Ambroise-Pare Hartmann, Neuilly-sur-Seine, France|Hôpital Américain de PARIS, Neuilly-sur-Seine, France|CHU de Nimes, Nîmes, France|CHR Orleans, Orléans, France|CHP Sainte-Marie, Osny, France|Diaconesses Croix Saint-Simon Hospital Complex, Paris, France|Centre hospitalier de Pau, Pau, France|CARIO - Hopital Privé des Cotes d'Armor, Plérin, France|CHU de Poitiers, Poitiers, France|Institut Godinot, Reims, France|Clinique Mathilde - Les Hôpitaux Privés Rouennais, Rouen, France|Hia Begin, Saint-Mandé, France|CHU de Saint-Etienne, Saint-Étienne, France|CHU de Tours, Tours, France|Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France|CH Annecy Genevois, Épagny, France

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.

Primary Outcome Measures: 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., At baseline then every 3 months, up to 24 months|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., From randomization to death from any cause, up to 24 months|Overall survival, overall survival is the length of time from randomization during which patients enrolled in the study remain alive., From randomization to death from any cause, up to 24 months after last inclusion
Secondary Outcome Measures: 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., 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., 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)., 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., 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., 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., 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., 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., 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., 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., 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)., 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, Throughout study completion, up to 24 months after randomization