Enhancing breast cancer research with wearable sensors and patient-reported outcomes

Bridging the gap: How wearables and patient reports improve breast cancer research

Kelly Dumais, Ph.D. – Director, eCOA Science & Consulting at Clario
Adam Jagodinsky, Ph.D. – Principal Scientific Advisor, Precision Motion at Clario

Introduction 

Breast cancer research has made significant strides in recent years, thanks to advancements in pharmaceuticals, technology and methodologies. Clinical outcome assessments (COAs) play a crucial role in understanding treatment effectiveness and the overall quality of life (QoL) experienced by patients. However, traditional COAs often rely on subjective measures, leaving gaps in our understanding of patient functioning. In this article, we explore the potential of wearable sensors to supplement COAs in breast cancer research and explore their correlation with patient-reported outcomes (PROs).

The role of wearable sensors

Wearable sensors, like Clario’s Opal^® device, offer a novel approach to gathering objective data on patient functioning. Unlike traditional COAs, which rely on patient self-reporting and clinician assessments, wearable sensors provide objective measures of gait, balance, and physical activity. This data offers valuable insights into patient behavior and health status, particularly during active prescribed movement tasks or passive monitoring.

Utilization in breast cancer research

To understand the current landscape of wearable sensor usage in breast cancer research, our eCOA and Precision Motion scientists conducted a non-systematic survey of the literature. Using electronic databases such as PubMed, Web of Science, Elsevier, and ClinicalTrials.gov, they were able to identify oncology trials that incorporated both wearable sensors and PROs. Our survey included studies from various years without restrictions on publication date.

Key findings

Our survey revealed a growing interest in the integration of wearable sensors and PROs in breast cancer research. Researchers are utilizing a variety of wearable sensors, including accelerometers, heart rate monitors, and smartwatches, to gather data on physical activity, sleep patterns, and other relevant parameters. Both physical activity and sleep were the most common outcomes measured by wearables, which overlapped with PROs. These sensors complement traditional COAs by providing objective measures of patient functioning. 

Furthermore, our analysis highlighted the diverse outcomes measured in these studies, ranging from treatment adherence and symptom management to overall QoL assessments. Wearable sensors, together with PROs, offer researchers a greater understanding of patient experiences, allowing for personalized interventions and targeted support.  This can potentially lead to improved patient retention throughout the study.

Challenges and opportunities

One of the major challenges is that so few studies ran correlations between PRO data and wearable data. There is therefore much more potential to explore with how these measurements can complement each other. When leveraging the immense benefits of wearable sensors in clinical research, issues such as data privacy, device interoperability, and patient compliance all need to be addressed to maximize their utility.  Both technical and clinical validation are essential for adoption of digital health technologies in clinical trials. Technical validation is testing that the sensor measures what it intends to measure and clinical validation is testing that sensor and derived measures are sensitive in the planned clinical trial population. Additionally, there is a need for standardized methodologies and validated metrics, both technical and clinical, to ensure the reliability and validity of wearable sensor data.

Moving forward, the expanded use of wearable sensors and PROs in clinical breast cancer research holds great potential. By harnessing the power of objective data alongside PROs, researchers can gain an even more comprehensive understanding of patient functioning and treatment outcomes. This holistic approach not only enhances the quality of research, but also empowers patients by incorporating their perspectives into the research process.

Conclusion

Wearable sensors offer a valuable tool for enhancing breast cancer research by providing objective data on patient functioning. By integrating wearable sensors with PROs, researchers can gain unique insights into treatment effectiveness and QoL outcomes. As we continue to explore the potential of wearable technology in clinical research, it is essential to address challenges and collaborate across disciplines to realize its full benefits in breast cancer research and other clinical trials.

Written by

Kelly Dumais, Ph.D.

Director, eCOA Science & Consulting at Clario

Adam Jagodinsky, Ph.D.

Principal Scientific Advisor, Precision Motion at Clario