The Potential of Real-World Data from Breast Cancer Patients to Compare the Quality of Follow-Up in Chemotherapy or Radiotherapy Treatment

Real-world data, collected through devices and mobile applications, constitutes a valuable source of information about patients’ behaviours and routines. This information allows for evaluating the impact of treatments on their quality of life, making more informed decisions to mitigate side effects, and designing more effective strategies.

In this context, a second study has been launched this year in Spain by INCLIVA Biomedical Research Institute, through the research group of Dr Cristina Hernando, aiming to explore the potential of real-world data in breast cancer patients as a tool to compare the quality of follow-up for patients undergoing chemotherapy or radiotherapy.

The study, named REBECCA QoL (Quality of Life during treatment, Intervention trial), plans to include 110 patients from the Clinical University Hospital of Valencia, aged between 18 and 75 years, diagnosed with stage I, II, or III breast cancer, and who have started chemotherapy or radiotherapy treatment within the past 9 months as part of routine clinical practice.

Two groups of patients will be compared: a control group will follow the hospital standard care from their oncologist or nurse. An intervention group will additionally complete daily questionnaires and use a mobile application and a smartwatch to assess their quality of life and monitor their symptoms (heart rate, sleep time and quality, blood oxygen saturation level, daily steps, physiological stress, physical activity, etc.). This tool has the potential to serve as an instrument for patient follow-up and communication with healthcare personnel, providing greater attention to its users and to patients in other specialties.

The 12-month study is currently in the recruitment phase, which began in December of last year and is expected to conclude in June 2024. With around 42 patients recruited to date, the study is in a crucial stage where data is being meticulously collected and analysed to gain valuable insights that could inform future clinical interventions.

The recruitment process begins with patients visiting the Oncology Service of the hospital. During this visit, the patients receive information about the project and what their participation entails, appointments for their clinical exams (gynaecological and blood tests), and for the project workshop. Those who agree to participate sign an informed consent form.

One week after their medical visit, they attend the REBECCA’s training workshop, instructed by the research nurse. These workshops are held weekly in groups of 2 to 5 patients. In the workshop, patients download, install, and test the project’s mobile application, receive training on using the platform for data collection, and are provided with a smartwatch with instructions on its use.

Satisfaction with the follow-up and quality of life results will be analysed through forms that patients will complete semi-annually during one of their visits. Their responses will be analysed and compared with those of the control group, who will not use the application or smartwatch.