| NCT ID | NCT07190066 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Harokopio University |
| Condition | Breast Cancer Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-04-22 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Yannis Manios, Professor
PRINCIPAL INVESTIGATOR
Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece
Frequently Asked Questions
Who can join the NCT07190066 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07190066 currently recruiting?
Yes, NCT07190066 is actively recruiting participants. Contact the research team at manios@hua.gr for enrollment information.
Where is the NCT07190066 trial being conducted?
This trial is being conducted at Athens, Greece, Kaunas, Lithuania, Kaunas, Lithuania, Valencia, Spain and 3 additional locations.
Who is sponsoring the NCT07190066 clinical trial?
NCT07190066 is sponsored by Harokopio University. The principal investigator is Yannis Manios, Professor at Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece. The trial plans to enroll 300 participants.
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