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Data Collection Campaigns for Early Development Versions of the MELIORA Digital Tools
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.
The Multimodal Engagement and Sustainable Lifestyle Interventions Optimizing Breast Cancer Risk Reduction Supported by Artificial Intelligence (MELIORA) project addresses the urgent need for innovative, multifaceted approaches to breast cancer (BC) prevention. It promotes sustainable behaviour change through an AI-driven digital intervention. Central to the project is the development and evaluation of the MELIORA Virtual Coach (VC) app, designed to enhance awareness and motivation, and to support healthier lifestyle choices related to physical activity, diet, and alcohol consumption, while also addressing potential implementation barriers. The overall aim of the Data Collection Campaign (DCC) study is to gather comprehensive socio-demographic, health, lifestyle, and technology-usability data from the project's target participant groups to inform the development and refinement of the MELIORA digital tool and AI algorithms (i.e., the MELIORA app). The specific objectives of the study are to: * assess the usability of the early version of the MELIORA app and obtain suggestions for further refinement; * gather user feedback on the relevance, appropriateness, and usefulness of the app's educational content and format; * inform the design and development of acceptable strategies for behaviour change (e.g., reward strategies); * further develop AI algorithms for the MELIORA Virtual Coach based on user-provided information. This DCC pilot study is employing a prospective, exploratory design and is being conducted across four European countries (Greece, Sweden, Spain, and Lithuania) over a 5-month period (from first participant in to last participant out). Recruitment is being carried out through project sites as follows: (i) healthy women at risk of BC in Greece, Spain, and Lithuania; (ii) BC patients in Lithuania and Spain; and (iii) BC survivors in Lithuania and Sweden. The study aims to recruit a total of 300 participants, with target sample sizes of 156 healthy women at risk of BC (defined as not meeting healthy lifestyle recommendations), 58 BC patients, and 86 BC survivors. Participants will test and evaluate a preliminary version of the MELIORA app for 14 days. Findings from this pilot will provide valuable insights to guide the development of the MELIORA digital tools and AI algorithms, ultimately contributing to improved BC prevention and management through personalised recommendations and interventions.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
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
Start Date
April 22, 2025
Primary Completion Date
September 30, 2025
Completion Date
September 30, 2025
Last Updated
September 30, 2025
300
ESTIMATED participants
Data Collection campaign
OTHER
Lead Sponsor
Harokopio University
Collaborators
NCT06827704
NCT07200427
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT01299623