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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer, Breast Neoplasms, Quality of Life, Survivorship

Intervention / Treatment
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* Other: Xemio mobile application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth intervention<br>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. | Other: Xemio mobile application<br>* 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.<br>|
| No Intervention: Control<br>No application installed. Outcome measures collected every 3 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Health, mHealth, Quality of Life, Patient Support, eHealth