Breast Cancer PreventionDCCNCT07190066
MELIORA Data Collection Campaigns
A study testing Data Collection campaign in people with Breast Cancer Prevention, run by Harokopio University at 7 sites in 4 countries.
Trial summary
To support the development of the MELIORA digital app for the MELIORA main intervention, an initial pilot study (Data Collection Campaign, DCC) is being conducted with the three target participant groups: healthy women at increased risk of developing breast cancer (BC), BC patients, and BC survivors across the four… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Prevention
- What is being tested?
- Data Collection campaign
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 22 Apr 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals residing in Greece, Lithuania, Spain or Sweden.
- Female adults (i.e. ≥18 years of age).
- Ability to understand and complete the outcome measures in one of the participating countries' local languages.
- Ability to provide fully informed consent.
- Having access to and being able to use a smartphone that supports the project app (i.e., iOS or Android smartphone)
- Meeting the criteria for allocation to one of the three following groups:
Show all 9Show fewer
- Healthy women with a calculated Βody Μass Ιndex (BMI) ≥ 25 or not meeting the World Health Organization's recommendations of ≥150 minutes of moderate-to-vigorous physical activity per week.
- Women currently undergoing active treatment for breast cancer or awaiting to begin active treatment for breast cancer.
- Women survivors of BC having completed active treatment at least six months prior to study enrolment
Who cannot join
- Inability to provide fully informed consent.
- Inability to understand and communicate in one of the recruitment countries' local languages.
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
Lithuania2 sites, 2 recruiting
- Recruiting
Lietuvos Sveikatos Mokslų Universitetas (Lsmu)
Kaunas
Gintare Kaliniene, +370868409708, gintare.kaliniene@lsmu.lt
- Recruiting
Pagalbos Onkologiniams Ligoniams Asociacija (Pola L T)
Kaunas
Neringa Ciakiene, 9999999999, neringa@pola.lt
Spain2 sites, 2 recruiting
- Recruiting
Fundación Para El Fomento de La Investigación Sanitaria Y Biomédica de La Comunitat Valenciana (Fisabio)
Valencia
Ana Molina Barceló, 9999999999, ana.molina@fisabio.es
- Recruiting
INCLIVA - Instituto de Investigación Sanitaria
Valencia
Juan Miguel Cejalvo Andújar, 9999999999, juanmitch5@hotmail.com
Sweden2 sites, 2 recruiting
- Recruiting
Bröstcancerföreningen Amazona I Stockholms Län (Amazona)
Stockholm
Linda Engström, +46730620826, linda.engstrom@amazona.se
- Recruiting
Karolinska Institutet
Stockholm
Ioannis Ioakeimidis, 9999999999, ioannis.ioakimidis@ki.se
Greece1 site, 1 recruiting
- Recruiting
Harokopio University
Athens
Yannis Manios, Professor, +302109549156, manios@hua.gr
About this study
Official title: Data Collection Campaigns for Early Development Versions of the MELIORA Digital Tools
To support the development of the MELIORA digital app for the MELIORA main intervention, an initial pilot study (Data Collection Campaign, DCC) is being conducted with the three target participant groups: healthy women at increased risk of developing breast cancer (BC), BC patients, and BC survivors across the four intervention countries (Spain, Greece, Lithuania, Sweden). The planned sample size for each group is 156 healthy women at risk (defined as not meeting recommendations for a healthy lifestyle), 58 BC patients, and 86 BC survivors. Each participant is asked to test and evaluate a preliminary version of the MELIORA app over a 14-day period. The DCC takes place in the early stages of the project, as part of the intervention development phase, to inform the technical refinement and preliminary evaluation of the MELIORA digital app.
Read the detailed description
The Multimodal Engagement and Sustainable Lifestyle Interventions Optimizing Breast Cancer Risk Reduction Supported by Artificial Intelligence (MELIORA) project addresses the urgent need for innovative, multifaceted approaches to breast cancer (BC) prevention. It promotes sustainable behaviour change through an AI-driven digital intervention. Central to the project is the development and evaluation of the MELIORA Virtual Coach (VC) app, designed to enhance awareness and motivation, and to support healthier lifestyle choices related to physical activity, diet, and alcohol consumption, while also addressing potential implementation barriers.
The overall aim of the Data Collection Campaign (DCC) study is to gather comprehensive socio-demographic, health, lifestyle, and technology-usability data from the project's target participant groups to inform the development and refinement of the MELIORA digital tool and AI algorithms (i.e., the MELIORA app). The specific objectives of the study are to:
- assess the usability of the early version of the MELIORA app and obtain suggestions for further refinement;
- gather user feedback on the relevance, appropriateness, and usefulness of the app's educational content and format;
- inform the design and development of acceptable strategies for behaviour change (e.g., reward strategies);
- further develop AI algorithms for the MELIORA Virtual Coach based on user-provided information.
This DCC pilot study is employing a prospective, exploratory design and is being conducted across four European countries (Greece, Sweden, Spain, and Lithuania) over a 5-month period (from first participant in to last participant out). Recruitment is being carried out through project sites as follows: (i) healthy women at risk of BC in Greece, Spain, and Lithuania; (ii) BC patients in Lithuania and Spain; and (iii) BC survivors in Lithuania and Sweden. The study aims to recruit a total of 300 participants, with target sample sizes of 156 healthy women at risk of BC (defined as not meeting healthy lifestyle recommendations), 58 BC patients, and 86 BC survivors. Participants will test and evaluate a preliminary version of the MELIORA app for 14 days.
Findings from this pilot will provide valuable insights to guide the development of the MELIORA digital tools and AI algorithms, ultimately contributing to improved BC prevention and management through personalised recommendations and interventions.
- Conditions
- Breast Cancer Prevention
- Being tested
- Data Collection campaign
- Keywords
- Behaviors 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
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data Collection campaignOther
Participants will be asked to download the MELIROA app, compatible with iOS and Android, to their smartphones and test it for 14 days. The app will prompt the user to set a weekly goal on physical activity and support daily self-monitoring and step count tracking. Τhe app will also offer culturally adapted educational material through mini-courses, motivational and practical tips and an embedded library of materials relevant to physical activity, healthy diet and alcohol consumption. To boost motivation, it will also include reminders and gamification features like badges and points.
| Study group | Role | What they receive |
|---|---|---|
| DCC participants | Experimental | Participants will recieve a preliminary version of the MELIORA VCI app Receives: Other: Data Collection campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability
Assessment of the usability of the first versions of the MELIORA app and users' feedback for further refinement. Participants' experiences and evaluations of the MELIORA app will be collected through a 29-item questionnaire developed for the purposes of the study. Initial questionnaire items were based on the mHealth App Usability Questionnaire (MAUQ) and the Trust in Technology framework, with additional items included to allow evaluations of specific app features. The questionnaire comprises 27 close-ended (with a 1-5 rating Likert scale) and 2 open-ended questions aiming to explore the usability and usefulness of the app, and participants' overall satisfaction with it.
Measured: 14 days
Relevance, appropriateness and usefulness
Users' feedback on the relevance, appropriateness and usefulness of the MELIORA app's educational content and format. Participants will be asked to evaluate the educational materials received, through a pop-up form which will occur at the end of their interaction with each material. The form will contain four questions (with a 1 to 5 rating Likert scale) aiming to gain participants' feedback on the usefulness, relevance, and comprehensibility of the provided materials
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start22 Apr 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study aims to recruit a total of 300 participants from the four study participating countries to interact with and evaluate the preliminary version of the MELIORA digital app.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN, FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA, Instituto de Investigacion Sanitaria INCLIVA, LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS, PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA, SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY, EUROPEAN FOOD INFORMATION COUNCIL, ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS, EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS, RISA SICHERHEITSANALYSEN GMBH, BioAssist, EUROPEAN HEALTH MANAGEMENT ASSOCIATION, ETICAS DATA SOCIETY, Karolinska Institutet, PredictBy Research and Consulting, S.L
- Responsible party
- Principal investigator, Yannis Manios, Harokopio University
- Investigators
- Yannis Manios, Professor, Principal investigator, Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190066
- Sponsor's protocol ID
- DCC101136791
- Acronym
- DCC
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study aiming to gather user feedback to improve the MELIORA digital app to be ready for the main MELIORA intervention.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection Campaigns for Early Development Versions of the MELIORA Digital Tools
- ClinicalTrials.gov ID
- NCT07190066
- Acronym / sponsor ID
- DCC / DCC101136791
- Conditions
- Breast Cancer Prevention
- Keywords
- Behaviors change, Disease prevention, Health behaviour, Primary prevention, Public and environmental health, Breast cancer, Cancer prevention, Sustainable intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN, FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA, Instituto de Investigacion Sanitaria INCLIVA, LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS, PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA, SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY, EUROPEAN FOOD INFORMATION COUNCIL, ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS, EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS, RISA SICHERHEITSANALYSEN GMBH, BioAssist, EUROPEAN HEALTH MANAGEMENT ASSOCIATION, ETICAS DATA SOCIETY, Karolinska Institutet, PredictBy Research and Consulting, S.L
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To support the development of the MELIORA digital app for the MELIORA main intervention, an initial pilot study (Data Collection Campaign, DCC) is being conducted with the three target participant groups: healthy women at increased risk of developing breast cancer (BC), BC patients, and BC survivors across the four intervention countries (Spain, Greece, Lithuania, Sweden). The planned sample size for each group is 156 healthy women at risk (defined as not meeting recommendations for a healthy lifestyle), 58 BC patients, and 86 BC survivors. Each participant is asked to test and evaluate a preliminary version of the MELIORA app over a 14-day period. The DCC takes place in the early stages of the project, as part of the intervention development phase, to inform the technical refinement and preliminary evaluation of the MELIORA digital app.
Detailed description
The Multimodal Engagement and Sustainable Lifestyle Interventions Optimizing Breast Cancer Risk Reduction Supported by Artificial Intelligence (MELIORA) project addresses the urgent need for innovative, multifaceted approaches to breast cancer (BC) prevention. It promotes sustainable behaviour change through an AI-driven digital intervention. Central to the project is the development and evaluation of the MELIORA Virtual Coach (VC) app, designed to enhance awareness and motivation, and to support healthier lifestyle choices related to physical activity, diet, and alcohol consumption, while also addressing potential implementation barriers.
The overall aim of the Data Collection Campaign (DCC) study is to gather comprehensive socio-demographic, health, lifestyle, and technology-usability data from the project's target participant groups to inform the development and refinement of the MELIORA digital tool and AI algorithms (i.e., the MELIORA app). The specific objectives of the study are to:
- assess the usability of the early version of the MELIORA app and obtain suggestions for further refinement;
- gather user feedback on the relevance, appropriateness, and usefulness of the app's educational content and format;
- inform the design and development of acceptable strategies for behaviour change (e.g., reward strategies);
- further develop AI algorithms for the MELIORA Virtual Coach based on user-provided information.
This DCC pilot study is employing a prospective, exploratory design and is being conducted across four European countries (Greece, Sweden, Spain, and Lithuania) over a 5-month period (from first participant in to last participant out). Recruitment is being carried out through project sites as follows: (i) healthy women at risk of BC in Greece, Spain, and Lithuania; (ii) BC patients in Lithuania and Spain; and (iii) BC survivors in Lithuania and Sweden. The study aims to recruit a total of 300 participants, with target sample sizes of 156 healthy women at risk of BC (defined as not meeting healthy lifestyle recommendations), 58 BC patients, and 86 BC survivors. Participants will test and evaluate a preliminary version of the MELIORA app for 14 days.
Findings from this pilot will provide valuable insights to guide the development of the MELIORA digital tools and AI algorithms, ultimately contributing to improved BC prevention and management through personalised recommendations and interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study aims to recruit a total of 300 participants from the four study participating countries to interact with and evaluate the preliminary version of the MELIORA digital app.
| Arm | Type | Receives |
|---|---|---|
| DCC participants | Experimental | Other: Data Collection campaignParticipants will recieve a preliminary version of the MELIORA VCI app |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Individuals residing in Greece, Lithuania, Spain or Sweden.
- Female adults (i.e. ≥18 years of age).
- Ability to understand and complete the outcome measures in one of the participating countries' local languages.
- Ability to provide fully informed consent.
- Having access to and being able to use a smartphone that supports the project app (i.e., iOS or Android smartphone)
Key exclusion criteria (2 listed)
- Inability to provide fully informed consent.
- Inability to understand and communicate in one of the recruitment countries' local languages.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data Collection campaignParticipants will be asked to download the MELIROA app, compatible with iOS and Android, to their smartphones and test it for 14 days. The app will prompt the user to set a weekly goal on physical activity and support daily self-monitoring and step count tracking. Τhe app will also offer culturally adapted educational material through mini-courses, motivational and practical tips and an embedded library of materials relevant to physical activity, healthy diet and alcohol consumption. To boost motivation, it will also include reminders and gamification features like badges and points. | Other | DCC participants |
Primary outcome
Usability
Time frame: 14 days
Assessment of the usability of the first versions of the MELIORA app and users' feedback for further refinement. Participants' experiences and evaluations of the MELIORA app will be collected through a 29-item questionnaire developed for the purposes of the study. Initial questionnaire items were based on the mHealth App Usability Questionnaire (MAUQ) and the Trust in Technology framework, with additional items included to allow evaluations of specific app features. The questionnaire comprises 27 close-ended (with a 1-5 rating Likert scale) and 2 open-ended questions aiming to explore the usability and usefulness of the app, and participants' overall satisfaction with it.
Relevance, appropriateness and usefulness
Time frame: 14 days
Users' feedback on the relevance, appropriateness and usefulness of the MELIORA app's educational content and format. Participants will be asked to evaluate the educational materials received, through a pop-up form which will occur at the end of their interaction with each material. The form will contain four questions (with a 1 to 5 rating Likert scale) aiming to gain participants' feedback on the usefulness, relevance, and comprehensibility of the provided materials
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- MELIORA website linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. This is a pilot study aiming to gather user feedback to improve the MELIORA digital app to be ready for the main MELIORA intervention.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yannis Manios, Professor principal investigator
Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data Collection campaign in people with Breast Cancer Prevention, run by Harokopio University at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Lithuania, Spain, Sweden, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yannis Manios, Professor (+30 2109549156, manios@hua.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025; AzTrials last refreshed its copy on 27 Oct 2026.