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

Fundacion Clinic per a la Recerca Biomédica

Status: Completed

Conditions: Breast Cancer; Quality of Life; Survivorship; Breast Neoplasms

Treatments: Other: Xemio mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT05401643

HCB/2020/0971

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

mHealth intervention

Experimental group

Description:

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.

Treatment:

Other: Xemio mobile application

Control

No Intervention group

Description:

No application installed. Outcome measures collected every 3 months.