MELIORA Data Collection Campaigns
ConditionBreast Cancer Prevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHarokopio University
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Inability to provide fully informed consent.
Inability to understand and communicate in one of the recruitment countries' local languages.
Trial design
Design model
Single group
Treatments tested in this trial
Data Collection campaign
Other interventionParticipants 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: DCC participantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Usability
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.
Time frame
14 days2
Relevance, appropriateness and usefulness
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
Time frame
14 daysSponsors and contacts
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Harokopio University
Lead sponsor
BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN
Collaborator
FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA
Collaborator
Instituto de Investigacion Sanitaria INCLIVA
Collaborator
LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS
Collaborator
PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA
Collaborator
SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY
Collaborator
EUROPEAN FOOD INFORMATION COUNCIL
Collaborator
ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS
Collaborator
EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS
Collaborator
RISA SICHERHEITSANALYSEN GMBH
Collaborator
BioAssist
Collaborator
EUROPEAN HEALTH MANAGEMENT ASSOCIATION
Collaborator
ETICAS DATA SOCIETY
Collaborator
Karolinska Institutet
Collaborator
PredictBy Research and Consulting, S.L
Collaborator
Source ClinicalTrials.gov