MELIORA Virtual Coach Intervention for Breast Cancer Prevention

NCT07200427 | Not Yet Recruiting

• 1 other identifier: 101136791
• Study Type: interventional
• Target: 2,080
• Locations: 4 countries
• Sites: 7

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.

Conditions

Breast Cancer Prevention

Keywords

Behavior change; Disease prevention; Health behaviour; Primary prevention; Public and environmental health; Breast cancer; Cancer prevention; Sustainable intervention; Nutrition; Diet; Physical activity; Exercise; Lifestyle; Public health; Cancer risk factors; Health communication; Digital health; Health technologies; Artificial intelligence; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From baseline (T0) until the end of the six-month intervention period (T1)

Secondary Outcomes (30)

• Physical activity levels - MVPA minutes

  From Baseline (T0) until the end of the six-month intervention period (T1)

• Physical activity levels - MVPA minutes

  From Baseline (T0) until the end of the 6-month follow-up period (T2)

• Physical activity levels - MVPA minutes

  From Baseline (T0) until the end of the 6-month follow-up period (T2)

• Physical activity levels - Step count

  From Baseline (T0) until the end of the six-month intervention period (T1)

• Physical activity levels - Step count

  From Baseline (T0) until the end of the 6-month follow-up period (T2)

Other Outcomes (12)

• Body mass index (BMI)

  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

  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

  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)

Study Arms (2)

MELIORA Virtual Coach Intervention (VCI) Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention.

Other: Control (generic advice)

Interventions

MELIORA Virtual Coach Intervention BEHAVIORAL

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.

MELIORA Virtual Coach Intervention (VCI) Group

Control (generic advice) OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harokopio University: lead
• 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 SA: collaborator
• EUROPEAN HEALTH MANAGEMENT ASSOCIATION: collaborator
• ETICAS DATA SOCIETY: collaborator

Study Sites (7)

Harokopio University

Athens, Greece

Location

Lietuvos Sveikatos Mokslų Universitetas (Lsmu)

Kaunas, Lithuania

Location

Pagalbos Onkologiniams Ligoniams Asociacija (Pola L T)

Kaunas, Lithuania

Location

Fundación Para El Fomento de La Investigación Sanitaria Y Biomédica de La Comunitat Valenciana (Fisabio)

Valencia, Spain

Location

INCLIVA - Instituto de Investigación Sanitaria

Valencia, Spain

Location

Bröstcancerföreningen Amazona I Stockholms Län (Amazona)

Stockholm, Sweden

Location

Karolinska Institutet

Stockholm, Sweden

Location

Related Links

• MELIORA website link

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Yannis Manios, Professor

  Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannis Manios, Professor

CONTACT

+30 2109549156; manios@hua.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The MELIORA RCTs will employ a parallel-group, randomized controlled design with two groups: an intervention group and a control group. The study follows a superiority design, with individual-level randomization and a 1:1 allocation ratio.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 1, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

GR (1); LI (2); ES (2); SE (2)