RecruitingNot Applicable

MELIORA Data Collection Campaigns

Greece, Lithuania, Spain300 participantsStarted 2025-04-22

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion Criteria: * 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 Exclusion Criteria: * Inability to provide fully informed consent. * Inability to understand and communicate in one of the recruitment countries' local languages.

What they're measuring

Usability

Timeframe: 14 days

Relevance, appropriateness and usefulness

Timeframe: 14 days

Trial details

NCT IDNCT07190066

SponsorHarokopio University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

Contact for this trial

Yannis Manios, Professor

+30 2109549156 manios@hua.gr