Evaluation of the Impact of a Multidimensional ICT Intervention on the Quality of Life of Breast Cancer Survivors
NCT ID: NCT05401643
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
110 participants
INTERVENTIONAL
2020-11-01
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 875351.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life
NCT04174248
Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.
NCT05196269
Socio-aesthetic Intervention on Body Image and Quality of Life in Women With Breast Cancer.
NCT00210145
Improving Adherence Healthy Lifestyle With a Smartphone Application Based After Surgery in Cancer Patients
NCT01915043
Use of Intraoperative Radiotherapy in Breast Cancer
NCT07030231
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
mHealth intervention
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.
Xemio mobile application
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.
Control
No application installed. Outcome measures collected every 3 months.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Xemio mobile application
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Active treatment for cancer (chemotherapy, radiotherapy)
* Comorbidities such as heart failure NYHA class 4, COPD,...
* Inability to give informed consent
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundacion iSYS, internet, salud y sociedad
UNKNOWN
Fundacion Clinic per a la Recerca Biomédica
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Imma Grau
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Imma Grau, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Clínic
Barcelona, Catalonia, Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HCB/2020/0971
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.