About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Inability to provide fully informed consent.
Inability to understand and communicate in one of the recruitment countries' local languages.
Trial design
Treatments tested in this trial
- Data Collection campaign
Treatment groups
Sponsors and collaborators
Harokopio University
Lead sponsor
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
Collaborator
EUROPEAN HEALTH MANAGEMENT ASSOCIATION
Collaborator
ETICAS DATA SOCIETY
Collaborator
Karolinska Institutet
Collaborator
PredictBy Research and Consulting, S.L
Collaborator