Clinical trial · Interventional
Evaluation of the Impact of a Multidimensional ICT Intervention on the Quality of Life of Breast Cancer Survivors
Evaluación Del Impacto de Una intervención Multidimensional, Con Herramientas TIC, en la Calidad de Vida de Las Pacientes Supervivientes al cáncer de Mama
- 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)
mACMA is a pilot study that is developed for breast cancer survivors of the Hospital Clinic of Barcelona. The objective of this study is to evaluate the progress in quality of life through the introduction of a mobile phone App that allows for symptom tracking, physical activity tracking and a calendar of patient-oriented events organized by patient organizations. This study is a two-arm randomized clinical trial. This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 875351.
Conditions
Conditions (4)
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Quality of Life | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Xemio mobile application | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- mHealth intervention
- description
- Installation of the mHealth application Xemio in the participant's smartphones. Voluntary use of the application for 12 months. Outcome measures collected every 3 months.
- interventionNames
- Other: Xemio mobile application
- type
- NO_INTERVENTION
- label
- Control
- description
- No application installed. Outcome measures collected every 3 months.
Primary outcomes (2)
- measure
- Change in Quality of Life of cancer patients
- timeFrame
- Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)
- description
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). Measured as 0-100.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previous diagnostic of breast cancer * Free of disease at the time of randomization * Signed consent form * Possession of a smartphone and ability to use smartphone applications * Patients belonging to the ACMA group o being treated at Hospital Clínic * Without diagnosis of neurodegenerative disorders that prevent participation in the study Exclusion Criteria: * Acute process of cancer at the moment of recruitment * Active treatment for cancer (chemotherapy, radiotherapy) * Comorbidities such as heart failure NYHA class 4, COPD,... * Inability to give informed consent
References
Publications (2)
- DERIVEDFuentes-Exposito MA, Frid S, Munoz-Mateu M, Grau-Corral I. Effect of a Multidimensional Digital Health Intervention on Quality of Life in Breast Cancer Survivors: A Randomized Controlled Trial. JCO Clin Cancer Inform. 2026 Apr;10(2):e2600025. doi: 10.1200/CCI-26-00025. Epub 2026 Jun 26. PMID 42361286
- DERIVEDFuentes-Exposito MA, Frid S, Munoz-Mateu M, Siso-Almirall A, Armayones Ruiz M, Grau-Corral I. Feasibility of the Xemio app for breast cancer survivors in a clinical setting: Adherence, acceptance, and side effect monitoring (CTCAE vs. QoL). PLoS One. 2026 May 13;21(5):e0342702. doi: 10.1371/journal.pone.0342702. eCollection 2026. PMID 42127092