MELIORA Data Collection Campaigns

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.

NCT Number	NCT07190066
Lead Sponsor	Harokopio University 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
Conditions	Breast Cancer Prevention
Enrollment	300 participants
Start Date	2025-04-22
Primary Completion	2025-09-30 (estimated)
Study Completion	2025-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-30