About this trial
Breast cancer (BC) is the most commonly diagnosed cancer in women worldwide, with early-onset cases increasing due to genetic and lifestyle factors. Traditional prevention strategies have shown limited effectiveness, creating the need for innovative approaches. The MELIORA project develops an AI-driven digital tool, the Virtual Coach (VC), to promote sustainable behaviour change in physical activity, diet, and alcohol use. Three randomized-controlled studies will be conducted: MELIORA-HEALTHY (women at risk, n=1080 in Greece, Lithuania, Spain), MELIORA-PATIENTS (women undergoing treatment, n=400 in Lithuania, Spain), and MELIORA-SURVIVORS (post-treatment survivors, n=600 in Lithuania, Spain, Sweden). Participants across diverse regions and backgrounds will be randomized to standard lifestyle advice or the same advice plus the MELIORA VC app. Each study lasts 12 months, with outcomes assessed at baseline, 6, and 12 months. The primary outcome is physical activity, with secondary outcomes including sedentary behaviour, diet, alcohol use, and quality of life. If effective, the MELIORA VC could offer a scalable, cost-effective model for BC prevention and survivorship care, providing valuable evidence to guide public health strategies.
Eligibility criteria
Qualifiers
Reside in Greece, Lithuania, or Spain.
Be female and at least 18 years of age.
Have access to and be able to use a smartphone (iOS or Android) compatible with the MELIORA app.
Be willing and able to use the MELIORA app for the entire study duration.
Disqualifiers
Inability to provide fully informed consent.
Inability to understand or communicate in the local language i.e. Greek in Greece, Lithuanian in Lithuania, Spanish in Spain.
Current or past diagnosis of cancer or other uncontrolled chronic diseases (e.g., cardiovascular disease, diabetes) that affect lifestyle, dietary habits, or communication skills.
Mental illness or disorders that affect lifestyle, dietary habits, or communication skills.
Trial design
Treatments tested in this trial
- MELIORA Virtual Coach Intervention
- Control (generic advice)
Treatment groups
Sponsors and collaborators
Harokopio University
Lead sponsor
BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN
Collaborator
Karolinska Institutet
Collaborator
Instituto de Investigacion Sanitaria INCLIVA
Collaborator
FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA
Collaborator
LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS
Collaborator
PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA
Collaborator
SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY
Collaborator
EUROPEAN FOOD INFORMATION COUNCIL
Collaborator
PredictBy Research and Consulting, S.L
Collaborator
ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS
Collaborator
EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS
Collaborator
RISA SICHERHEITSANALYSEN GMBH
Collaborator
BioAssist
Collaborator
EUROPEAN HEALTH MANAGEMENT ASSOCIATION
Collaborator
ETICAS DATA SOCIETY
Collaborator