MELIORA Virtual Coach Intervention for Breast Cancer Prevention

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer Prevention

• Registration Number: NCT07200427
• Lead Sponsor: Harokopio University

Brief 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.

Detailed Description

Breast cancer (BC) is the most commonly diagnosed cancer among women worldwide, with early-onset cases rising rapidly due to interactions between genetics and lifestyle behaviours. Traditional efforts to modify these behaviours have had limited success, highlighting the need for innovative, multifaceted approaches. The Multimodal Engagement and Sustainable Lifestyle Interventions Optimizing Breast Cancer Risk Reduction Supported by Artificial Intelligence (MELIORA) project addresses this gap by promoting sustainable behaviour change through an innovative intervention using artificial intelligence (AI). The project will develop and evaluate an AI-driven behaviour change digital solution, the MELIORA virtual coach (VC), designed to enhance awareness, motivation, and promote healthier lifestyle choices related to physical activity, diet, and alcohol consumption, while addressing potential implementation barriers.

The MELIORA VC intervention consists of three separate studies: 1) the MELIORA-HEALTHY Study targeting healthy women at risk of BC (conducted in Greece, Lithuania, Spain), 2) the MELIORA-PATIENTS Study targeting BC patients (conducted in Lithuania, Spain), and 3) the MELIORA-SURVIVORS Study targeting BC survivors (conducted in Lithuania, Spain, Sweden), involving a total of 2,080 participants. The studies will encompass both urban and rural regions and will include participants across the socioeconomic spectrum and/or ethnic minority groups, allowing for the evaluation of how these factors moderate the effectiveness of the MELIORA behavioural change intervention. The studies will follow a randomized-controlled design. For the MELIORA-HEALTHY study, a total of 1080 adult women (360 per site), free of cancer and with at least one behavioural (i.e. low levels of physical activity, unhealthy diet, increased alcohol consumption) or metabolic (i.e. increased BMI) risk factor will be recruited. For the MELIORA-PATIENTS study, a total of 400 adult women diagnosed with BC and currently undergoing treatment (200 per site) will be recruited. For the MELIORA-SURVIVORS study, a total of 600 adult women diagnosed with BC and have completed primary therapy (200 per site) will be recruited.

Participants at each site will be randomly assigned (1:1 allocation) to either the intervention group or the control group. The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention. The intervention group will receive the same generic advice along with the MELIORA VC intervention app. The total study duration for each participant will be 12 months, divided into two six-month periods: the intervention period and the follow-up period. Targeted behaviours will be assessed at three time points: baseline (0 months), end of the six-month intervention period (6 months), and end of the six-month follow-up period (12 months). The primary outcome that will be assessed is physical activity while secondary outcomes include sedentary behaviours, diet, alcohol consumption and health-related quality of life.

The MELIORA project represents an innovative approach to BC prevention by integrating an AI-driven digital health solution into real-world settings. The MELIORA studies highlight the role of technology in promoting sustainable behaviour change to prevent the onset or recurrence of BC. The VC tool that will be developed, tested and evaluated is a key outcome of the MELIORA project and aims to support preventive policies and health promotion guidelines for BC prevention. If successful, the MELIORA VC model could be expanded to other at-risk populations, reinforcing the potential of AI-driven, cost-effective health interventions in cancer prevention. Findings will provide valuable insights for policymakers and healthcare professionals on the feasibility, effectiveness, and cost-effectiveness of AI-supported lifestyle interventions, shaping future public health strategies.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Study Start: 2025-12-01
• Primary Completion: 2027-04
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 2080

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical activity levels - MVPA minutes	From baseline (T0) until the end of the six-month intervention period (T1)	The primary outcome will be the mean change in physical activity levels as measured by MVPA minutes from baseline at the end of the six-month intervention period between the intervention and the control group.
Physical activity levels - Step count	From baseline (T0) until the end of the six-month intervention period (T1)	The primary outcome will be the mean change in physical activity levels as measured by step count from baseline at the end of the six-month intervention period between the intervention and the control group.

Secondary Outcome Measures

Name	Time	Method
Physical activity levels - MVPA minutes	From Baseline (T0) until the end of the 6-month follow-up period (T2)	Mean changes in physical activity levels as measured by MVPA minutes, from baseline until the end of the 6-month follow-up period within groups.
Physical activity levels - Step count	From Baseline (T0) until the end of the 6-month follow-up period (T2)	Mean changes in physical activity levels as measured by step count, from baseline until the end of the 6-month follow-up period, within groups.
Aerobic exercise minutes	From Baseline (T0) until the end of the 6-month follow-up period (T2)	Mean changes in aerobic exercise minutes, from baseline until the end of the 6-month follow-up period, within groups.
Muscle strengthening minutes	From Baseline (T0) until the end of the 6-month follow-up period (T2)	Mean changes in muscle strengthening minutes, from baseline until the end of the 6-month follow-up period, between groups.
Sedentary minutes	From Baseline (T0) until the end of the 6-month follow-up period (T2)	Mean changes in sedentary minutes, from baseline until the end of the 6-month follow-up period, between groups.
Αlcohol consumption	From Baseline (T0) until the end of the 6-month follow-up period (T2)	Mean changes in alcohol consumption (servings/week), from baseline until the end of the 6-month follow-up period, between groups.
Diet quality	From Baseline (T0) until the end of the 6-month follow-up period (T2)	Mean changes in diet score and individual dietary components, from baseline until the end of the 6-month follow-up period, between groups.
Health-related quality of life	From Baseline (T0) until the end of the 6-month follow-up period (T2)	Mean changes in quality of life \[EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L, scale 1-5 with greatest values meaning worst outcomes)\], from baseline until the end of the 6-month follow-up period between groups.

Trial Locations

Locations (7)

Harokopio University; 🇬🇷 Athens, Greece

Lietuvos Sveikatos Mokslų Universitetas (Lsmu); 🇱🇹 Kaunas, Lithuania

Pagalbos Onkologiniams Ligoniams Asociacija (Pola L T); 🇱🇹 Kaunas, Lithuania

Fundación Para El Fomento de La Investigación Sanitaria Y Biomédica de La Comunitat Valenciana (Fisabio); 🇪🇸 Valencia, Spain

INCLIVA - Instituto de Investigación Sanitaria; 🇪🇸 Valencia, Spain

Bröstcancerföreningen Amazona I Stockholms Län (Amazona); 🇸🇪 Stockholm, Sweden

Karolinska Institutet; 🇸🇪 Stockholm, Sweden