RecruitingNot Applicable

MELIORA Virtual Coach Intervention for Breast Cancer Prevention

Greece, Lithuania, Spain2,080 participantsStarted 2026-03-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: MELIORA-HEALTHY study participants must meet all of the following criteria in order to be deemed eligible for study participation: * 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. * Willing to provide informed consent to participate in the study. * Have at least one of the following behavioural or metabolic risk factors for BC, assessed in a random order (each site may determine the order that is most convenient for them) until eligibility is confirmed. If a risk factor is identified, the subsequent assessments can be skipped: * Increased alcohol consumption: More than 1 drink per day. * Increased body mass index (BMI): BMI ≥ 25 kg/m² or waist circumference ≥80 cm for normal weight individuals. * Physical inactivity: Not meeting World Health Organization (WHO) guidelines of at least 150 minutes of moderate-intensity or 75 minutes of high-intensity aerobic exercise per week during the last month. * Suboptimal diet: Low diet quality based on the rapid Prime Diet Quality Score Screener (rPDQS). MELIORA-PATIENTS study participants must meet all of the following criteria in order to be deemed eligible for study participation: * Reside in Spain or Lithuania. * Be female and at least 18 years old. * Have access to and be able to use a smartphone (iOS or …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Physical activity levels - MVPA minutes

Timeframe: From baseline (T0) until the end of the six-month intervention period (T1)

Physical activity levels - Step count

Timeframe: From baseline (T0) until the end of the six-month intervention period (T1)

Trial details

NCT IDNCT07200427

SponsorHarokopio University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Yannis Manios, Professor

+30 2109549156 manios@hua.gr

View on ClinicalTrials.gov More Breast Cancer Prevention trials