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| Name | Class |
|---|---|
| Fundacion iSYS, internet, salud y sociedad | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mHealth intervention | Experimental | 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. |
|
| Control | No Intervention | No application installed. Outcome measures collected every 3 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xemio mobile application | Other | The study consists in a mHealth intervention provided through the Xemio mobile application for breast cancer survivors. This application is installed in the personal smartphones of the participants after they are randomized in the mHealth intervention group. The Xemio app components are symptom tracking, up-to-date calendar of events organized by patient's organizations, virtual talks with experts, articles regarding new information of the disease, physical activity tracking, and evidence-based information regarding symptoms, non-pharmacological treatments for side effects, and information about common drugs to treat breast cancer. The participants can freely use the Xemio mobile application for a total of 12 months. The control group does not have access to the Xemio application for the duration of the study but they are offered access to it at the completion of the intervention. The participants of both arms continued to receive the usual care from their oncology teams. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life of cancer patients | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). Measured as 0-100. | Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study) |
| Change in Quality of Life specific to breast cancer patients | European Organisation for Research and Treatment of Cancer Breast 23 (EORTC BR-23). Measured as 0-100. | Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety and Depression | Hospital Anxiety and Depression Scale (HADS). Measured as 0-21, 0 being the best and 21 being the worst. | Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study) |
| Change in Loneliness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imma Grau, PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic | Barcelona | Catalonia | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42361286 | Derived | Fuentes-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. | |
| 42127092 | Derived | Fuentes-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. |
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Individual participant data will not shared as it is stated in the approved informed consent and protocol approved by the institution's Ethics Committee. Some of the data collected in this study contains clinical information, hence it is sensible information that needs to remain private.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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This study is designed as a prospective, longitudinal, randomized 1:1 trial, with two arms: a control group and an intervention group. The intervention will be 12 months long for each participant. There will be a total of 150 participants. Half (75) will comprise the control group and half (75 more) the intervention group. Only the intervention group will have access to the Xemio mobile app.
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|
Three-Item Loneliness Scale. Measured as 0-9, 0 being the best, 9 being the worst.
| Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study) |
| Steps | Number of steps taken daily by study participants | Continuous (12 months) |
| Change in Weight | Weight (kg) measured with a bioimpedance scale | Baseline and t= 12 months |
| Change in Body Mass Index (BMI) | BMI (kg/m^2) measured with a bioimpedance scale | Baseline and t= 12 months |
| Change in Fat mass percentage | Fat mass percentage measured with a bioimpedance scale | Baseline and t= 12 months |
| Change in muscle mass percentage | Muscle mass percentage measured with a bioimpedance scale | Baseline and t= 12 months |
| Change in Social Determinants of Health | Smoking status, education level, employment status, zip code, alcoholic beverage consumption, civil status | Baseline and t= 12 months |
| Symptoms reported with the Xemio mobile application | Continuous (12 months) |
| Use of the Xemio mobile application | Time that the Xemio mobile application is open in minutes | Continuous (12 months) |
| D017437 |
| Skin and Connective Tissue Diseases |