MELIORA Data Collection Campaigns

Official title

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

Overview

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

• Other Data 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 mo

Primary outcome measures

• Usability [Time frame: 14 days]
• Relevance, appropriateness and usefulness [Time frame: 14 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Lithuania · 2 centers

• Lietuvos Sveikatos Mokslų Universitetas (Lsmu) — Kaunas
• Pagalbos Onkologiniams Ligoniams Asociacija (Pola L T) — Kaunas

Spain · 2 centers

• Fundación Para El Fomento de La Investigación Sanitaria Y Biomédica de La Comunitat Valenc — Valencia
• INCLIVA - Instituto de Investigación Sanitaria — Valencia

Sweden · 2 centers

• Bröstcancerföreningen Amazona I Stockholms Län (Amazona) — Stockholm
• Karolinska Institutet — Stockholm

Greece · 1 center

• Harokopio University — Athens

Identifiers

NCT: NCT07190066 · DCC101136791

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗