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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05401643
• Other study ID #: HCB/2020/0971
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 30, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Quality of Life
• Survivorship

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica	Fundacion iSYS, internet, salud y sociedad

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	Steps	Number of steps taken daily by study participants	Continuous (12 months)
Secondary	Change in Weight	Weight (kg) measured with a bioimpedance scale	Baseline and t= 12 months
Secondary	Change in Body Mass Index (BMI)	BMI (kg/m^2) measured with a bioimpedance scale	Baseline and t= 12 months
Secondary	Change in Fat mass percentage	Fat mass percentage measured with a bioimpedance scale	Baseline and t= 12 months
Secondary	Change in muscle mass percentage	Muscle mass percentage measured with a bioimpedance scale	Baseline and t= 12 months
Secondary	Change in Social Determinants of Health	Smoking status, education level, employment status, zip code, alcoholic beverage consumption, civil status	Baseline and t= 12 months
Secondary	Symptoms reported with the Xemio mobile application		Continuous (12 months)
Secondary	Use of the Xemio mobile application	Time that the Xemio mobile application is open in minutes	Continuous (12 months)