MELIORA Virtual Coach Intervention for Breast Cancer Prevention

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.

NCT Number	NCT07200427
Lead Sponsor	Harokopio University Collaborators: BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN, Karolinska Institutet, Instituto de Investigacion Sanitaria INCLIVA, FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA, LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS, PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA, SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY, EUROPEAN FOOD INFORMATION COUNCIL, PredictBy Research and Consulting, S.L, ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS, EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS, RISA SICHERHEITSANALYSEN GMBH, BioAssist, EUROPEAN HEALTH MANAGEMENT ASSOCIATION, ETICAS DATA SOCIETY
Conditions	Breast Cancer Prevention
Enrollment	2,080 participants
Start Date	2026-03-01
Primary Completion	2027-09 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-06-15