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Breast CancerNCT05401643

Evaluation of the Impact of a Multidimensional ICT Intervention on the Quality of Life of Breast Cancer Survivors

A study testing Xemio mobile application in people with Breast Cancer and Breast Neoplasms, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Breast Neoplasms, Quality of Life
What is being tested?
Xemio mobile application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteSpain
Study dates
1 Nov 2020to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clínic

    Barcelona, Catalonia, 08036

Other trials in Spain

About this study

Official title: Evaluación Del Impacto de Una intervención Multidimensional, Con Herramientas TIC, en la Calidad de Vida de Las Pacientes Supervivientes al cáncer de Mama

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.

Being tested
Xemio mobile application
Keywords
Digital Health, mHealth, Quality of Life, Patient Support, eHealth
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xemio mobile applicationOther

    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.

Study groups in NCT05401643
Study groupRoleWhat they receive
mHealth interventionExperimentalInstallation of the mHealth application Xemio in the participant's smartphones. Voluntary use of the application for 12 months. Outcome measures collected every 3 months.
Receives: Other: Xemio mobile application
ControlNo interventionNo application installed. Outcome measures collected every 3 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)

  2. 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.

    Measured: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)

Secondary outcomes (10)

  1. Change in Anxiety and Depression

    Hospital Anxiety and Depression Scale (HADS). Measured as 0-21, 0 being the best and 21 being the worst.

    Measured: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)

  2. Change in Loneliness

    Three-Item Loneliness Scale. Measured as 0-9, 0 being the best, 9 being the worst.

    Measured: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)

  3. Steps

    Number of steps taken daily by study participants

    Measured: Continuous (12 months)

  4. Change in Weight

    Weight (kg) measured with a bioimpedance scale

    Measured: Baseline and t= 12 months

  5. Change in Body Mass Index (BMI)

    BMI (kg/m^2) measured with a bioimpedance scale

    Measured: Baseline and t= 12 months

  6. Change in Fat mass percentage

    Fat mass percentage measured with a bioimpedance scale

    Measured: Baseline and t= 12 months

  7. Change in muscle mass percentage

    Muscle mass percentage measured with a bioimpedance scale

    Measured: Baseline and t= 12 months

  8. Change in Social Determinants of Health

    Smoking status, education level, employment status, zip code, alcoholic beverage consumption, civil status

    Measured: Baseline and t= 12 months

  9. Symptoms reported with the Xemio mobile application

    Measured: Continuous (12 months)

  10. Use of the Xemio mobile application

    Time that the Xemio mobile application is open in minutes

    Measured: Continuous (12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2022
  2. Study start1 Nov 2020
  3. Primary completion30 Nov 2022
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05401643
Sponsor's protocol ID
HCB/2020/0971
Status last verified
Feb 2024
First submitted
23 May 2022
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 42361286

  • 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.

    PubMed 42127092

Questions about this trial

What is this clinical trial studying?

A study testing Xemio mobile application in people with Breast Cancer and Breast Neoplasms, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Quality of Life of cancer patients (time frame: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05401643, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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