MELIORA Data Collection Campaigns

NCT07190066 | Recruiting

• 1 other identifier: DCC101136791
• Study Type: interventional
• Target: 300
• Locations: 4 countries
• Sites: 7

Brief 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 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.

Conditions

Breast Cancer Prevention

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  14 days

Study Arms (1)

DCC participants

EXPERIMENTAL

Participants will recieve a preliminary version of the MELIORA VCI app

Other: Data Collection campaign

Interventions

Data Collection campaign OTHER

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.

DCC participants

Eligibility Criteria

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

You may qualify if:

• 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:
• 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

You may not qualify if:

• Inability to provide fully informed consent.
• Inability to understand and communicate in one of the recruitment countries' local languages.

Sponsors & Collaborators

• Harokopio University: lead
• BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN: collaborator
• FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA: collaborator
• Instituto de Investigacion Sanitaria INCLIVA: collaborator
• LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS: collaborator
• PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA: collaborator
• SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY: collaborator
• EUROPEAN FOOD INFORMATION COUNCIL: 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
• Karolinska Institutet: collaborator
• PREDICTBY RESEARCH AND CONSULTING S.L.: collaborator

Study Sites (7)

Harokopio University

Athens, Greece

RECRUITING

Lietuvos Sveikatos Mokslų Universitetas (Lsmu)

Kaunas, Lithuania

RECRUITING

Pagalbos Onkologiniams Ligoniams Asociacija (Pola L T)

Kaunas, Lithuania

RECRUITING

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

Valencia, Spain

RECRUITING

INCLIVA - Instituto de Investigación Sanitaria

Valencia, Spain

RECRUITING

Bröstcancerföreningen Amazona I Stockholms Län (Amazona)

Stockholm, Sweden

RECRUITING

Karolinska Institutet

Stockholm, Sweden

RECRUITING

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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: April 22, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

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