Clinical trial · Interventional
MELIORA Data Collection Campaigns
Data Collection Campaigns for Early Development Versions of the MELIORA Digital Tools
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Prevention | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data Collection campaign | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DCC participants
- description
- Participants will recieve a preliminary version of the MELIORA VCI app
- interventionNames
- Other: Data Collection campaign
Primary outcomes (2)
- measure
- Usability
- timeFrame
- 14 days
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
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