MELIORA data collection to develop a breast cancer prevention app
Official title: Data Collection Campaigns for Early Development Versions of the MELIORA Digital Tools
Run by Harokopio University · NCT07190066 · Data updated 2026-11-12
This two-week pilot will test a preliminary MELIORA smartphone app with women at increased breast cancer risk, women undergoing treatment, and survivors in Spain, Greece, Lithuania, and Sweden.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Harokopio University Academic / other |
| Locations | 7 sites (Athens and 6 other locations) |
| Status | Recruiting |
| Started | April 22, 2025 |
| Main results expected | September 30, 2025 |
| Study ends | September 30, 2025 |
| Registry record updated | September 30, 2025 |
| Trial ID | NCT07190066 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women (18+) living in Greece, Lithuania, Spain, or Sweden who can read a local language, consent, use an iOS or Android smartphone, and fit one of three groups (BMI ≥25 or <150 min/week activity for at-risk; currently in active treatment; or survivor ≥6 months post-treatment).
✕Probably not a fit
People without a compatible smartphone, who cannot read a participating local language, cannot give informed consent, or do not belong to the three target groups are unlikely to benefit from this pilot.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The Data Collection Campaign is a short prospective pilot in which target participants use a preliminary MELIORA app for 14 days and provide usability and lifestyle information. The study recruits three groups—healthy women at increased risk, women currently receiving breast cancer treatment, and survivors who finished treatment at least six months earlier—across four countries. Planned sample sizes are roughly 156 at-risk women, 58 patients, and 86 survivors, and participants provide sociodemographic, health, lifestyle, and technology-feedback data. Collected data will inform technical refinements, educational content, reward strategies, and preliminary AI algorithm development for the MELIORA Virtual Coach.
Why it matters
Potential benefit: If successful, the app could help women adopt healthier behaviors related to activity, diet, and alcohol use through personalized AI-supported coaching, potentially lowering breast cancer risk.
How similar studies have gone: Previous digital lifestyle programs have shown modest success changing diet and activity, but using an AI-driven virtual coach specifically for breast cancer prevention is relatively novel and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Harokopio University
Athens, Greece Recruiting -
Lietuvos Sveikatos Mokslų Universitetas (Lsmu)
Kaunas, Lithuania Recruiting -
Pagalbos Onkologiniams Ligoniams Asociacija (Pola L T)
Kaunas, Lithuania Recruiting -
Fundación Para El Fomento de La Investigación Sanitaria Y Biomédica de La Comunitat Valenciana (Fisabio)
Valencia, Spain Recruiting -
INCLIVA - Instituto de Investigación Sanitaria
Valencia, Spain Recruiting -
Bröstcancerföreningen Amazona I Stockholms Län (Amazona)
Stockholm, Sweden Recruiting
Show 1 more location
-
Karolinska Institutet
Stockholm, Sweden Recruiting
Study contacts
- Principal investigator: Yannis Manios, Professor — Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece
- Study coordinator: Yannis Manios, Professor
- Email: manios@hua.gr
- Phone: +30 2109549156
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Active Mammography and Counseling to Increase Breast Cancer Screening
This program will test whether community education, patient navigation, and provider engagement can help women aged 40–74 in selected Puerto Rican municipalities who are overdue for mammograms get screened.
-
MELIORA: a digital coach to help prevent breast cancer
A digital AI coach tests whether plus standard lifestyle advice can help women reduce breast cancer risk by improving activity, diet, and alcohol habits.
-
Understanding how genes affect breast cancer risk
This study is trying to see how genes affect the risk of breast cancer by collecting health surveys and saliva samples from people aged 18 and older in the US.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.