Multimodal Engagement and Sustainable Lifestyle Interventions Optimizing Breast Cancer Risk Reduction Supported by Artificial Intelligence
Trial ID: NCT07200427
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-12
Completion date: 2027-04
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: Breast Cancer Prevention
Interventions: MELIORA Virtual Coach Intervention; Control (generic advice)
Locations: Harokopio University; Lietuvos Sveikatos Mokslų Universitetas (Lsmu); Pagalbos Onkologiniams Ligoniams Asociacija (Pola L T); Fundación Para El Fomento de La Investigación Sanitaria Y Biomédica de La Comunitat Valenciana (Fisabio); INCLIVA - Instituto de Investigación Sanitaria; Bröstcancerföreningen Amazona I Stockholms Län (Amazona); Karolinska Institutet
Countries: Greece; Lithuania; Lithuania; Spain; Spain; Sweden; Sweden
Enrollment: 2080
Age range: 18 Years - None
Sex: FEMALE

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.

Eligibility criteria:
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.
* 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.
* 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.

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.
* 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.
* 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.
* 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).

Outcomes:
Physical activity levels - MVPA minutes; Physical activity levels - Step count