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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Breast Cancer; Breast Neoplasms; Survivorship
• Intervention / Treatment: Other: Xemio mobile application

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: Control; No application installed. Outcome measures collected every 3 months.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Collaborators: Fundacion iSYS, internet, salud y sociedad
• Investigators: Principal Investigator: Imma Grau, PhD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; mHealth; eHealth; Digital Health; Patient Support
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HCB/2020/0971

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No