MELIORA Virtual Coach Intervention for Breast Cancer Prevention
NCT ID: NCT07200427
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
2080 participants
INTERVENTIONAL
2025-12-31
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Improving Lifestyle Behavior by "Joven, Fuerte y Saludable" Multidisciplinary Program.
NCT06090747
Participation Restrictions in Breast Cancer Survivors
NCT01225328
Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer
NCT03529383
A New Tool to Promote Patient's Engagement in Their Healthcare Process
NCT06762496
Web-based Intervention for Long-term Breast Cancer Survivors
NCT05322460
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MELIORA Virtual Coach Intervention (VCI) Group
The intervention group will receive generic advice on a healthy lifestyle and breast cancer (BC) prevention plus access to the full MELIORA VCI app.
MELIORA Virtual Coach Intervention
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.
Control Group
The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention.
Control (generic advice)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MELIORA Virtual Coach Intervention
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.
Control (generic advice)
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN
UNKNOWN
Karolinska Institutet
OTHER
Instituto de Investigacion Sanitaria INCLIVA
OTHER
FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA
UNKNOWN
LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS
UNKNOWN
PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA
UNKNOWN
SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY
UNKNOWN
EUROPEAN FOOD INFORMATION COUNCIL
UNKNOWN
PREDICTBY RESEARCH AND CONSULTING S.L.
UNKNOWN
ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS
UNKNOWN
EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS
UNKNOWN
RISA SICHERHEITSANALYSEN GMBH
UNKNOWN
BIOASSIST SA
UNKNOWN
EUROPEAN HEALTH MANAGEMENT ASSOCIATION
UNKNOWN
ETICAS DATA SOCIETY
UNKNOWN
Harokopio University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yannis Manios
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yannis Manios, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
MELIORA website link
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
101136791
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.