Abstract
An objective evaluation of patient performance status (PS) is difficult because patients spend the majority of their time outside of the clinic, self-report to providers, and undergo dynamic changes throughout their treatment experience. Real-time, objective activity data may allow for a more accurate assessment of PS and physical function, while reducing the subjectivity and bias associated with current assessments. Consenting patients with advanced cancer wore a wearble activity monitor for three consecutive visits in a prospective, single-cohort clinical trial. Provider-assessed PS (ECOG/Karnofsky) and NIH PROMIS® patient-reported outcomes (PROs) were assessed at each visit. Associations between wearable activity monitor metrics (steps, distance, stairs) and PS, clinical outcomes (adverse events, hospitalizations, survival), and PROs were assessed using correlation statistics and in multivariable logistic regression models. Thirty-seven patients were evaluated (54% male, median 62 years). Patients averaged 3700 steps, 1.7 miles, and 3 flights of stairs per day. Highest correlations were observed between average daily steps and ECOG-PS and KPS (r = 0.63 and r = 0.69, respectively p < 0.01). Each 1000 steps/day increase was associated with reduced odds for adverse events (OR: 0.34, 95% CI 0.13, 0.94), hospitalizations (OR: 0.21 95% CI 0.56, 0.79), and hazard for death (HR: 0.48 95% CI 0.28–0.83). Significant correlations were also observed between activity metrics and PROs. Our trial demonstrates the feasibility of using wearable activity monitors to assess PS in advanced cancer patients and suggests their potential use to predict clinical and patient-reported outcomes. These findings should be validated in larger, randomized trials.
Highlights
Cancer patients require an accurate assessment of performance status and physical function to inform treatment decisions and determine eligibility into clinical trials
Pain, and depression scores increased and reported sleep quality and physical functioning decreased as Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) increased
We found that the wearable activity monitor was feasible for use, especially for the estimation of step counts over a short period of time
Summary
Cancer patients require an accurate assessment of performance status and physical function to inform treatment decisions and determine eligibility into clinical trials. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (1960) and the Karnofsky Performance Status (KPS) (1949) are common scales used for assessing a patient’s level of function and ability of self-care.[1,2] Despite their routine use and value in oncology, there are several limitations associated with these scales. These scales are subjective and physicianreported, leading to the potential for under- or overestimation of a patient’s performance status.[3,4,5] For instance, a physician’s intent to provide therapy or enroll a patient into a clinical trial may inadvertently result in overestimation of physical function and can further increase the patient’s risk for toxicities and treatment intolerance.[5] an underestimation of physical robustness may result in under treatment, which can subsequently affect a patient’s clinical outcomes and quality of life. Recall may be influenced by a patient’s desire to enroll in a trial or receive therapy, resulting in the over reporting of their physical activity levels and function
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