Breast Cancer, Breast Neoplasms, Quality of Life, Survivorship
Conditions
Keywords
Digital Health, mHealth, Quality of Life, Patient Support, eHealth
Brief 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 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.
Interventions
OTHERXemio 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.
Sponsors
Fundacion iSYS, internet, salud y sociedad
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life of cancer patients | Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study) | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). Measured as 0-100. |
| Change in Quality of Life specific to breast cancer patients | Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study) | European Organisation for Research and Treatment of Cancer Breast 23 (EORTC BR-23). Measured as 0-100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Steps | Continuous (12 months) | Number of steps taken daily by study participants |
| Change in Weight | Baseline and t= 12 months | Weight (kg) measured with a bioimpedance scale |
| Change in Body Mass Index (BMI) | Baseline and t= 12 months | BMI (kg/m\^2) measured with a bioimpedance scale |
| Change in Fat mass percentage | Baseline and t= 12 months | Fat mass percentage measured with a bioimpedance scale |
| Change in Anxiety and Depression | Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study) | Hospital Anxiety and Depression Scale (HADS). Measured as 0-21, 0 being the best and 21 being the worst. |
| Change in Social Determinants of Health | Baseline and t= 12 months | Smoking status, education level, employment status, zip code, alcoholic beverage consumption, civil status |
| Symptoms reported with the Xemio mobile application | Continuous (12 months) | — |
| Use of the Xemio mobile application | Continuous (12 months) | Time that the Xemio mobile application is open in minutes |
| Change in muscle mass percentage | Baseline and t= 12 months | Muscle mass percentage measured with a bioimpedance scale |
| Change in Loneliness | Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study) | Three-Item Loneliness Scale. Measured as 0-9, 0 being the best, 9 being the worst. |
Countries
Spain
Outcome results
None listed