MELIORA Virtual Coach Intervention for Breast Cancer Prevention

Summary

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.

Conditions

• Breast Cancer Prevention

Interventions

BEHAVIORAL

MELIORA Virtual Coach Intervention

Based on baseline assessments, the MELIORA VCI app will prompt intervention group participants to set weekly goals on lifestyle behaviours such as physical activity, diet, alcohol use, and sedentary time, and support daily self-monitoring and step count tracking. Goals will be dynamically adjusted by the virtual coach or the participant to remain realistic and achievable. Τhe app will also offer culturally adapted educational, motivational, and instructional support through mini-courses, tips, recommendations and an embedded library of relevant materials to ensure high adoption rates among women from diverse countries, socioeconomic backgrounds and minority groups. To boost motivation, it will include reminders, gamification features like badges and points, as well as personalized techniques such as action planning, problem solving, social reward, and positive self-talk.

OTHER

Control (generic advice)

The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention. A 'light' version of the MELIORA VCI app will be developed to host the control group materials, track participants' step counts, send reminders, and allow scheduling of follow-up visits. No other features will be available in this version of the app.

Sponsors & Collaborators

• BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN

  collaborator UNKNOWN

• Karolinska Institutet

  collaborator OTHER

• Instituto de Investigacion Sanitaria INCLIVA

  collaborator INDUSTRY

• FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA

  collaborator UNKNOWN

• LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS

  collaborator UNKNOWN

• PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA

  collaborator UNKNOWN

• SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY

  collaborator UNKNOWN

• EUROPEAN FOOD INFORMATION COUNCIL

  collaborator UNKNOWN

• PREDICTBY RESEARCH AND CONSULTING S.L.

  collaborator UNKNOWN

• ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS

  collaborator UNKNOWN

• EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS

  collaborator UNKNOWN

• RISA SICHERHEITSANALYSEN GMBH

  collaborator UNKNOWN

• BIOASSIST SA

  collaborator UNKNOWN

• EUROPEAN HEALTH MANAGEMENT ASSOCIATION

  collaborator UNKNOWN

• ETICAS DATA SOCIETY

  collaborator UNKNOWN

• Harokopio University

  lead OTHER

Principal Investigators

• Yannis Manios, Professor · Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-12-31

Primary Completion

2027-04-30

Completion

2027-04-30

Countries

• Greece
• Lithuania
• Spain
• Sweden

Study Locations