MELIORA Virtual Coach Intervention for Breast Cancer Prevention
ConditionBreast Cancer Prevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHarokopio University
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
MELIORA Virtual Coach Intervention
BehavioralBased 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.
Control (generic advice)
Other interventionThe 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.
Treatment groups
2,080 Participants
are divided into 2 treatment groupsGroup A: MELIORA Virtual Coach Intervention (VCI) GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)2
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)3
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)4
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)Other outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Harokopio University
Lead sponsor
BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN
Collaborator
Karolinska Institutet
Collaborator
Instituto de Investigacion Sanitaria INCLIVA
Collaborator
FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA
Collaborator
LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS
Collaborator
PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA
Collaborator
SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY
Collaborator
EUROPEAN FOOD INFORMATION COUNCIL
Collaborator
PredictBy Research and Consulting, S.L
Collaborator
ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS
Collaborator
EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS
Collaborator
RISA SICHERHEITSANALYSEN GMBH
Collaborator
BioAssist
Collaborator
EUROPEAN HEALTH MANAGEMENT ASSOCIATION
Collaborator
ETICAS DATA SOCIETY
Collaborator
Source ClinicalTrials.gov