Data Collection Campaigns for Early Development Versions of the MELIORA Digital Tools
Trial ID: NCT07190066
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-04-22
Completion date: 2025-09-30
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
Interventions: Data Collection campaign
Locations: Harokopio University; Lietuvos Sveikatos Mokslų Universitetas (Lsmu); Pagalbos Onkologiniams Ligoniams Asociacija (Pola L T); Fundación Para El Fomento de La Investigación Sanitaria Y Biomédica de La Comunitat Valenciana (Fisabio); INCLIVA - Instituto de Investigación Sanitaria; Bröstcancerföreningen Amazona I Stockholms Län (Amazona); Karolinska Institutet
Countries: Greece; Lithuania; Lithuania; Spain; Spain; Sweden; Sweden
Enrollment: 300
Age range: 18 Years - None
Sex: FEMALE

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 criteria:
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.

Outcomes:
Usability; Relevance, appropriateness and usefulness