Status:
RECRUITING
MELIORA Data Collection Campaigns
Lead Sponsor:
Harokopio University
Collaborating Sponsors:
BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN
FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA
Conditions:
Breast Cancer Prevention
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 gro...
Detailed Description
The Multimodal Engagement and Sustainable Lifestyle Interventions Optimizing Breast Cancer Risk Reduction Supported by Artificial Intelligence (MELIORA) project addresses the urgent need for innovativ...
Eligibility Criteria
Inclusion
- 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
- Inability to provide fully informed consent.
- Inability to understand and communicate in one of the recruitment countries' local languages.
Key Trial Info
Start Date :
April 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07190066
Start Date
April 22 2025
End Date
September 30 2025
Last Update
September 30 2025
Active Locations (7)
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1
Harokopio University
Athens, Greece
2
Lietuvos Sveikatos Mokslų Universitetas (Lsmu)
Kaunas, Lithuania
3
Pagalbos Onkologiniams Ligoniams Asociacija (Pola L T)
Kaunas, Lithuania
4
Fundación Para El Fomento de La Investigación Sanitaria Y Biomédica de La Comunitat Valenciana (Fisabio)
Valencia, Spain