MELIORA Data Collection Campaigns

Not Applicable

Recruiting

• Conditions: Breast Cancer Prevention

• Registration Number: NCT07190066
• Lead Sponsor: Harokopio University

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.

Study Timeline

• Study Start: 2025-04-22
• Status Verified: 2025-09
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-16
• Study First Posted: 2025-09-24
• Last Update Submitted: 2025-09-25
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30
• Last Update Posted: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

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