Wearable activity monitors for assessing outcomes in cancer clinical trials

Clinical Trials;Oncology;Wearable Technology;Outcome measurement;Epidemiology

Gresham, GillianMorss Dy, Sydney ;

Johns Hopkins University

关键词: Clinical Trials;    Oncology;    Wearable Technology;    Outcome measurement;    Epidemiology;   

Others  :  https://jscholarship.library.jhu.edu/bitstream/handle/1774.2/60207/GRESHAM-DISSERTATION-2017.pdf?sequence=1&isAllowed=y

瑞士|英语

来源: JOHNS HOPKINS DSpace Repository

【 摘 要 】

Technology plays a significant role in improving outcome measurement and advancing healthcare across many disciplines. Recent technological advances in wearable devices, such as activity monitors, have created new opportunities to collect continuous, objective patient data in a non-obtrusive manner. This dissertation addresses the application of wearable activity monitors in clinical trials to measure and predict cancer outcomes. Wearable activity monitors measure movement to calculate the number of steps taken, distance travelled, stairs climbed, calories burned, sleep duration, and heart rate, among other metrics. Summaries of patient activity data can provide more detailed information related to a cancer patient’s functional status and overall well-being. The first aim of the dissertation was to identify and characterize current applications of wearable activity monitors in cancer clinical trials from the published literature. Research gaps identified from the literature review informed the subsequent design of a clinical trial that used a wearable activity monitor, the Fitbit Charge HR®, to measure outcomes in advanced cancer patients being treated at Cedars-Sinai Medical Center. Trial objectives included: (1) Measuring the association between activity metrics (steps, stairs, sleep, heart rate) and provider-assessed functional outcomes;(2) Measuring the association between activity metrics and patient-reported outcomes; (3) Estimating the ability of activity metrics to predict overall survival, hospitalizations, and the occurrence of adverse events.Our literature review identified 41 randomized controlled trials that used wearable activity monitors in cancer patients and were published between 2005 and 2015. The majority of clinical trials involved cancer survivors (63%) and most devices were used as measures of adherence or as motivators in exercise or behavioral trials. There are current research gaps in the use of wearable activity monitors among patients undergoing active cancer treatment. Few studies have evaluated the use of wearable activity monitors to assess clinical outcomes such as performance status, toxicities, or survival. Results from our clinical trial suggest that consumer-based wearable activity monitors (e.g., Fitbit Charge HR) were feasible for use in 37 consenting patients diagnosed with advanced cancer. We found significant correlations between activity metrics derived from the wearable monitors and provider-assessed performance status using gold-standard ECOG and Karnofsky scales. Activity monitor data were also significantly associated with patient-reported outcomes including fatigue, pain, physical functioning, and emotional well-being. Decreasing step counts were the strongest predictors of adverse events and hospitalizations, while higher levels of physical activity, were associated with improved survival outcomes. The integration of wearable activity monitors into cancer care has potential to improve our ability to measure important clinical outcomes, while reducing the burden associated with standard patient assessment. Furthermore, the collection of objective, continuous data can provide a more accurate picture of a patient’s overall health and activity patterns, thus reducing bias and informing treatment decisions. We find ourselves in an exciting time, where technology is increasingly being used to facilitate healthcare operations and communications. Thus, the contents of this dissertation help establish the foundation for future research using wearable technology in clinical trials.