Breast Cancer Prevention
Conditions
Keywords
Behaviors change, Disease prevention, Health behaviour, Primary prevention, Public and environmental health, Breast cancer, Cancer prevention, Sustainable intervention, Nutrition, Diet, Physical activity, Exercise, Lifestyle, Public health, Cancer risk factors, Health communication, Digital health, Health technologies, Artificial intelligence, randomized controlled trial
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.
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 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.
Interventions
OTHERData Collection campaign
Participants will be asked to download the MELIROA app, compatible with iOS and Android, to their smartphones and test it for 14 days. The app will prompt the user to set a weekly goal on physical activity and support daily self-monitoring and step count tracking. Τhe app will also offer culturally adapted educational material through mini-courses, motivational and practical tips and an embedded library of materials relevant to physical activity, healthy diet and alcohol consumption. To boost motivation, it will also include reminders and gamification features like badges and points.
Sponsors
BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN
FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA
Instituto de Investigacion Sanitaria INCLIVA
LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS
PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA
SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY
EUROPEAN FOOD INFORMATION COUNCIL
ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS
EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS
RISA SICHERHEITSANALYSEN GMBH
BIOASSIST SA
EUROPEAN HEALTH MANAGEMENT ASSOCIATION
ETICAS DATA SOCIETY
Karolinska Institutet
PREDICTBY RESEARCH AND CONSULTING S.L.
Harokopio University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The study aims to recruit a total of 300 participants from the four study participating countries to interact with and evaluate the preliminary version of the MELIORA digital app.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability | 14 days | Assessment of the usability of the first versions of the MELIORA app and users' feedback for further refinement. Participants' experiences and evaluations of the MELIORA app will be collected through a 29-item questionnaire developed for the purposes of the study. Initial questionnaire items were based on the mHealth App Usability Questionnaire (MAUQ) and the Trust in Technology framework, with additional items included to allow evaluations of specific app features. The questionnaire comprises 27 close-ended (with a 1-5 rating Likert scale) and 2 open-ended questions aiming to explore the usability and usefulness of the app, and participants' overall satisfaction with it. |
| Relevance, appropriateness and usefulness | 14 days | Users' feedback on the relevance, appropriateness and usefulness of the MELIORA app's educational content and format. Participants will be asked to evaluate the educational materials received, through a pop-up form which will occur at the end of their interaction with each material. The form will contain four questions (with a 1 to 5 rating Likert scale) aiming to gain participants' feedback on the usefulness, relevance, and comprehensibility of the provided materials |
Countries
Greece, Lithuania, Spain, Sweden
Contacts
Primary ContactYannis Manios, Professor
Outcome results
None listed