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Data Collection Campaigns for Early Development Versions of the MELIORA Digital Tools

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Greece
Harokopio University
RECRUITING
Athens
Lithuania
Lietuvos Sveikatos Mokslų Universitetas (Lsmu)
RECRUITING
Kaunas
Pagalbos Onkologiniams Ligoniams Asociacija (Pola L T)
RECRUITING
Kaunas
Spain
Fundación Para El Fomento de La Investigación Sanitaria Y Biomédica de La Comunitat Valenciana (Fisabio)
RECRUITING
Valencia
INCLIVA - Instituto de Investigación Sanitaria
RECRUITING
Valencia
Sweden
Bröstcancerföreningen Amazona I Stockholms Län (Amazona)
RECRUITING
Stockholm
Karolinska Institutet
RECRUITING
Stockholm
Contact Information
Primary
Yannis Manios, Professor
manios@hua.gr
+30 2109549156
Time Frame
Start Date: 2025-04-22
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 300
Treatments
Experimental: DCC participants
Participants will recieve a preliminary version of the MELIORA VCI app
Related Therapeutic Areas
Sponsors
Collaborators: ETICAS DATA SOCIETY, SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY, Karolinska Institutet, FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA, PREDICTBY RESEARCH AND CONSULTING S.L., ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS, Instituto de Investigacion Sanitaria INCLIVA, BIOASSIST SA, BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN, LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS, RISA SICHERHEITSANALYSEN GMBH, EUROPEAN FOOD INFORMATION COUNCIL, EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS, EUROPEAN HEALTH MANAGEMENT ASSOCIATION, PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA
Leads: Harokopio University

This content was sourced from clinicaltrials.gov