An interventional study of MELIORA Virtual Coach Intervention and Control (generic advice) in Breast Cancer Prevention, sponsored by Harokopio University. Recruiting at 7 sites in 4 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Harokopio University · Not applicable, Interventional, and Prevention
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 2,080 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Harokopio University is the lead sponsor of 66 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
MELIORA-HEALTHY study participants must meet all of the following criteria in order to be deemed eligible for study participation:
MELIORA-PATIENTS study participants must meet all of the following criteria in order to be deemed eligible for study participation:
MELIORA-SURVIVORS study participants must meet all of the following criteria in order to be deemed eligible for study participation:
Exclusion Criteria:
MELIORA-HEALTHY study participants will be excluded from study participation if they meet any of the following criteria:
MELIORA PATIENTS and MELIORA SURVIVORS study participants will be excluded from study participation if they meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group will receive generic advice on a healthy lifestyle and breast cancer (BC) prevention plus access to the full MELIORA VCI app.
Behavioral: MELIORA Virtual Coach Intervention
The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention.
Other: Control (generic advice)
Based on baseline assessments, the MELIORA VCI app will prompt intervention group participants to set weekly goals on lifestyle behaviours such as physical activity, diet, alcohol use, and sedentary time, and support daily self-monitoring and step count tracking. Goals will be dynamically adjusted by the virtual coach or the participant to remain realistic and achievable. Τhe app will also offer culturally adapted educational, motivational, and instructional support through mini-courses, tips, recommendations and an embedded library of relevant materials to ensure high adoption rates among women from diverse countries, socioeconomic backgrounds and minority groups. To boost motivation, it will include reminders, gamification features like badges and points, as well as personalized techniques such as action planning, problem solving, social reward, and positive self-talk.
The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention. A 'light' version of the MELIORA VCI app will be developed to host the control group materials, track participants' step counts, send reminders, and allow scheduling of follow-up visits. No other features will be available in this version of the app.
Physical activity levels - MVPA minutes
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.
Time frame: From baseline (T0) until the end of the six-month intervention period (T1)
Physical activity levels - Step count
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.
Time frame: From baseline (T0) until the end of the six-month intervention period (T1)
Physical activity levels - MVPA minutes
Mean changes in physical activity levels as measured by MVPA minutes, from baseline until the end of the 6-month intervention period, within groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Physical activity levels - MVPA minutes
Mean changes in physical activity levels as measured by MVPA minutes, from baseline until the end of the 6-month follow-up period between groups.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Physical activity levels - MVPA minutes
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.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Physical activity levels - Step count
Mean changes in physical activity levels as measured by step count, from baseline until the end of the 6-month intervention period, within groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Physical activity levels - Step count
Mean changes in physical activity levels as measured by step count, from baseline until the end of the 6-month follow-up period, between groups.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Physical activity levels - Step count
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.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Aerobic exercise minutes
Mean changes in aerobic exercise minutes, from baseline until the end of the 6-month intervention period between groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Aerobic exercise minutes
Mean changes in aerobic exercise minutes, from baseline until the end of the 6-month intervention period, within groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Aerobic exercise minutes
Mean changes in aerobic exercise minutes, from baseline until the end of the 6-month follow-up period, between groups.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Aerobic exercise minutes
Mean changes in aerobic exercise minutes, from baseline until the end of the 6-month follow-up period, within groups.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Muscle strengthening minutes
Mean changes in muscle strengthening minutes, from baseline until the end of the 6-month intervention period within groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Muscle strengthening minutes
Mean changes in muscle strengthening minutes, from baseline until the end of the 6-month intervention period between groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Muscle strengthening minutes
Mean changes in muscle strengthening minutes, from baseline until the end of the 6-month follow-up period, within groups.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Muscle strengthening minutes
Mean changes in muscle strengthening minutes, from baseline until the end of the 6-month follow-up period, between groups.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Sedentary minutes
Mean changes in sedentary minutes, from baseline until the end of the 6-month intervention period between groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Sedentary minutes
Mean changes in sedentary minutes, from baseline until the end of the 6-month intervention period within groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Sedentary minutes
Mean changes in sedentary minutes, from baseline until the end of the 6-month follow-up period, within groups.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Sedentary minutes
Mean changes in sedentary minutes, from baseline until the end of the 6-month follow-up period, between groups.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Αlcohol consumption
Mean changes in alcohol consumption (servings/week), from baseline until the end of the 6-month intervention period within groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Αlcohol consumption
Mean changes in alcohol consumption (servings/week), from baseline until the end of the 6-month intervention period between groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Αlcohol consumption
Mean changes in alcohol consumption (servings/week), from baseline until the end of the 6-month follow-up period, within groups.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Αlcohol consumption
Mean changes in alcohol consumption (servings/week), from baseline until the end of the 6-month follow-up period, between groups.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Diet quality
Mean changes in rapid Prime Diet Quality Score Screener (rPDQS) diet score (0-26 points with higher scores meaning a better diet quality) and individual dietary components, from baseline until the end of the 6-month intervention period within groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Diet quality
Mean changes in rapid Prime Diet Quality Score Screener (rPDQS) diet score (0-26 points with higher scores meaning a better diet quality) and individual dietary components, from baseline until the end of the 6-month intervention period between groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Diet quality
Mean changes in rapid Prime Diet Quality Score Screener (rPDQS) diet score (0-26 points with higher scores meaning a better diet quality) and individual dietary components, from baseline until the end of the 6-month follow-up period, within groups.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Diet quality
Mean changes in diet score and individual dietary components, from baseline until the end of the 6-month follow-up period, between groups.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Health-related quality of life
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 intervention period within groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Health-related quality of life
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 intervention period between groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Health-related quality of life
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, within groups.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Health-related quality of life
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.
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Body mass index (BMI)
Mean changes in BMI, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2)
Role modelling behaviours
Mean changes in role modelling behaviours, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. An eleven-item tool was developed specifically for the purpose of this research to assess the potential impact of the intervention on health behaviours of participants' daughters. These items assess mothers' efforts to inform their daughter(s) about their participation in the intervention, to practise health behaviours in front of or along with their daughter(s), and to motivate their daughter(s) to also improve their health behaviours, as well as the perceived effect of mothers' participation on the daughter(s)' eating habits, physical activity, sedentary behaviour, alcohol consumption, and health literacy.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2)
Health literacy
Mean changes in health (European Health Literacy Survey Questionnaire (HLS-EU-Q) using 4-point Likert scales ranging from 1 = very easy to 4 = very difficult) from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2)
e-health literacy
Mean changes in e-health literacy (modified version of the Application subscale of the eHealth Literacy Scale in Web 3.0 context (eHLS Web 3.0) that uses 5-point Likert scales ranging from 1 = strongly disagree to 5 = strongly agree) from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2)
Psychosocial parameters - Physical capability
Mean changes in physical capability, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. Physical capability will be measured with a modified version of the physical competence subscales of the Physical Literacy in Adults Scale (PLAS), which assess one's perceived physical strength (3 items) and coordination/ balance (3 items) using 7-point Likert scales ranging from 1 = very untrue to 7 = very true.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2)
Psychosocial parameters - Psychological capability
Mean changes in psychological capability, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. A 6-item scale developed by Sniehotta, Scholz, \& Schwarzer (2005) and later adapted by Willmott, Pang, \& Rundle-Thiele (2021) will be used to assess the extent to which participants tried to self-monitor their physical activity behaviour (i.e., action control) in the last four weeks using 7-point Likert scales ranging from 1 = very untrue to 7 = very true.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2)
Psychosocial parameters - Psychological capability
Mean changes in psychological capability, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. A10-item scale (Sniehotta, Schwarzer, Scholz, \& Schüz, 2005) will be employed to assess the extent to which participants have planned when, where, how often, and how to engage in physical activity (i.e., action planning, 4 items) as well as how to overcome potential barriers for being physically active (i.e., coping planning, 6 items) using 4-point Likert scales ranging from 1 = completely disagree to 4 = totally agree.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2)
Psychosocial parameters - Social support for physical activity
Mean changes in social support for physical activity, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. Social support for physical activity will be measured with the Exercising together subscale (5 items) of the Social Support for Exercise Behaviour Scale (SSEBS) (Sallis, Grossman, Pinski, Patterson, \& Nader, 1987), as used in Howlett, Schulz, Trivedi, Troop, \& Chater (2019). Specifically, participants will indicate how often their friends and family members supported them in being physically active during the past three months using 5-point Likert scales ranging from 1 = none to 5 = very often.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2)
Psychosocial parameters - Reflective motivation
Mean changes in reflective motovation, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. The 5-item self-efficacy for physical activity scale by Marcus, Selby, Niaura, \& Rossi (1992) will be used to assess participants' confidence in their ability to perform physical activity under various challenging circumstances. The measurement instrument uses 5-point Likert scales ranging from 1 = not confident at all to 5 = extremely confident and has been extensively used in prior research to assess self-efficacy for physical activity.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2)
Psychosocial parameters - Automatic motoivation
Mean changes in automatic motivation, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. The International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) (Thomson, 2007) will be used to assess positive (5 items) and negative (5 items) affective responses towards physical activity, as used in Willmott, Pang, \& Rundle-Thiele (2021). The measurement instrument uses 5-point Likert scales ranging from 1 = never to 5 = always to assess to what extent an individual generally feels positive and negative emotions about physical activity.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2)
Psychosocial parameters - Injunctive social norms for physical activity
Mean changes in injunctive social norms for physical activity, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. Injunctive social norms for physical activity will be assessed with two items developed by Courneya, Friedenreich, Arthur, \& Bobick (1999), which measure the extent to which important others expect or support the individual to be physically active in the coming 4 months.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2)
Psychosocial parameters - Descriptive norms for physical activity
Mean changes in descriptive norms for physical activity, from baseline until the end of the 6-month intervention period and until the end of the 6-month follow-up period, within and between groups. Descriptive norms will be assessed with three items, measuring to what extent family, friends, and co-workers engage in physical activity themselves (Rhodes \& Courneya, 2003). Both measurement instruments use 7-point Likert scales ranging from 1 = strongly disagree to 7 = strongly agree.
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1) and from T0 until the end of the 6-month follow-up period (T2)
Plan to share: Undecided
Started Mar 2026 (actual). Primary completion is estimated for Sep 2027, 18 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 18 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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