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MELIORA Virtual Coach Intervention for Breast Cancer Prevention

Study acronym: MELIORA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary and study completion dates: Apr 2027 to Sep 2027
    • Start date changed from estimate of Dec 2025 to Mar 1, 2026
    • Eligibility criteria expanded, about 167 words
    • Site details revised at 7 of 7 sites
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Breast Cancer Prevention
Related terms Breast Neoplasms, Motor Activity
Enrollment 2,080 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov