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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
110
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.
Hospital Clínic
Barcelona, Catalonia, Spain
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.
Time frame: 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.
Time frame: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)
Change in Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS). Measured as 0-21, 0 being the best and 21 being the worst.
Time frame: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)
Change in Loneliness
Three-Item Loneliness Scale. Measured as 0-9, 0 being the best, 9 being the worst.
Time frame: 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
Time frame: Continuous (12 months)
Change in Weight
Weight (kg) measured with a bioimpedance scale
Time frame: Baseline and t= 12 months
Change in Body Mass Index (BMI)
BMI (kg/m\^2) measured with a bioimpedance scale
Time frame: Baseline and t= 12 months
Change in Fat mass percentage
Fat mass percentage measured with a bioimpedance scale
Time frame: Baseline and t= 12 months
Change in muscle mass percentage
Muscle mass percentage measured with a bioimpedance scale
Time frame: Baseline and t= 12 months
Change in Social Determinants of Health
Smoking status, education level, employment status, zip code, alcoholic beverage consumption, civil status
Time frame: Baseline and t= 12 months
Symptoms reported with the Xemio mobile application
Time frame: Continuous (12 months)
Use of the Xemio mobile application
Time that the Xemio mobile application is open in minutes
Time frame: Continuous (12 months)
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