Recruiting

MELIORA Data Collection Campaigns

ClinicalTrials.gov IDNCT07190066

PhaseNA

Enrollment300

SponsorHarokopio University

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer Prevention

About this study

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.

Interventions

Other: Data 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.

Primary outcomes

Usability (14 days)
Relevance, appropriateness and usefulness (14 days)

Eligibility information

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.

Study locations

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

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.