MELIORA Virtual Coach Intervention for Breast Cancer Prevention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHarokopio University

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

2,080 Participants
are divided into 2 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