Multimodal Engagement and Sustainable Lifestyle Interventions Optimizing Breast Cancer Risk Reduction Supported by Artificial Intelligence
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.
⁃ 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).