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AI virtual coach aims to cut breast cancer risk through lifestyle changes

NCT ID NCT07200427

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an AI-powered virtual coach app that helps women at risk for breast cancer set and track goals for physical activity, diet, and alcohol use. Over 2,000 women in Greece, Lithuania, Spain, and Sweden will be randomly assigned to standard advice or the app plus advice for 12 months. The goal is to see if the app leads to lasting healthy habits that could lower breast cancer risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MELIORA Virtual Coach app (behavioral intervention)
What this could lead to
If effective, this AI coach could offer a scalable, low-cost way to help women reduce their breast cancer risk through lifestyle changes.
What could go wrong
This is a behavioral study, not a drug trial, so results depend on user engagement. It may not show a strong effect on cancer rates, and benefits may vary by region or individual.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,080 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 been diagnosed with breast cancer (BC) within the last 6 months and/or currently undergoing treatment (chemotherapy, radiotherapy, immunotherapy, hormone therapy) and/or in active follow-up. * 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-SURVIVORS study participants must meet all of the following criteria in order to be deemed eligible for study participation: * Reside in Spain, Lithuania, or Sweden. * Be female and at least 18 years old. * 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 completed primary treatment for breast cancer (surgery, chemotherapy, radiotherapy, immunotherapy, targeted therapy, etc.) and currently be in remission. * Be considered "cancer-free" according to their treating physician and may enter the study immediately following this diagnosis. * Ongoing adjuvant hormone therapy is permitted. * 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 past month. * Suboptimal diet: Low diet quality based on the rapid Prime Diet Quality Score Screener (rPDQS). Exclusion Criteria: MELIORA-HEALTHY study participants will be excluded from study participation if they meet any of the following criteria: * 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. * Use of medication that affects lifestyle, dietary habits, or communication skills. * Recreational drug use. * Pregnancy, lactation, or intention to become pregnant shortly before, during, or after the intervention. * Participation in another clinical trial or program aimed at promoting behavioural changes or weight loss at the time of recruitment. If subjects already use health-related apps that affect their weight and lifestyle, including dietary habits and physical activity, the research team will ask them to pause their use until the end of the 12-month study period. However, the use of these applications by the participants cannot be controlled. MELIORA PATIENTS and MELIORA SURVIVORS study participants will be excluded from study participation if they meet any of the following criteria: * Inability to provide fully informed consent. * Inability to understand or communicate in the local language (i.e., Lithuanian in Lithuania, Spanish in Spain, Swedish in Sweden), unless appropriate translation support is available to ensure full understanding of study procedures and informed consent. * Current or past diagnosis of cancer (other than breast cancer, except skin cancer treated with surgery only) or other uncontrolled chronic diseases (e.g., cardiovascular diseases, diabetes) that affect lifestyle, dietary habits, or communication skills. * Mental illness or disorders that affect lifestyle, dietary habits, and communication skills. * Use of medication that affects lifestyle, dietary habits, or communication skills. * Recreational drug use. * Pregnancy, lactation, or intention to become pregnant shortly before, during, or after the intervention. * Participation in another clinical trial or program to promote behavioural changes or weight loss during recruitment. Suppose participants are already using health-related apps affecting their weight and lifestyle, including dietary habits and physical activity. In that case, they will be asked to suspend their use until the end of the 12-month study period. However, the research team cannot control the use of these applications by the participants. * Severe adherence issues with previous treatments that may interfere with compliance with study tasks (subject to the investigator's assessment).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bröstcancerföreningen Amazona I Stockholms Län (Amazona)

    RECRUITING

    Stockholm, Sweden

  • Fundación Para El Fomento de La Investigación Sanitaria Y Biomédica de La Comunitat Valenciana (Fisabio)

    RECRUITING

    Valencia, Spain

  • Harokopio University

    RECRUITING

    Athens, Greece

  • INCLIVA - Instituto de Investigación Sanitaria

    RECRUITING

    Valencia, Spain

  • Karolinska Institutet

    RECRUITING

    Stockholm, Sweden

  • Lietuvos Sveikatos Mokslų Universitetas (Lsmu)

    RECRUITING

    Kaunas, Lithuania

  • Pagalbos Onkologiniams Ligoniams Asociacija (Pola L T)

    RECRUITING

    Kaunas, Lithuania

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