RecruitingNot ApplicableNCT07190066

MELIORA Data Collection Campaigns

Data Collection Campaigns for Early Development Versions of the MELIORA Digital Tools

Sponsor

Harokopio University

Enrollment

300 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Prevention

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a smartphone app to collect health and activity data from women in Greece, Lithuania, Spain, and Sweden. The goal is to understand how physical activity and lifestyle affect health, particularly for women with breast cancer and healthy women who are less active. **You may be eligible if...** - You are a woman (18 or older) living in Greece, Lithuania, Spain, or Sweden - You can use an iOS or Android smartphone that supports the study app - You fall into one of these groups: (1) a healthy woman with a BMI of 25 or above or who does not meet recommended physical activity levels; (2) a woman currently undergoing breast cancer treatment or about to begin; or (3) a breast cancer survivor who finished treatment at least 6 months ago - You can understand and complete the questionnaires in your local language **You may NOT be eligible if...** - You cannot provide informed consent - You cannot communicate in one of the study countries' languages Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERData Collection campaign

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.

Locations(7)

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

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