Abstract
BackgroundPatients, who discontinue early, do not benefit from phase I/II clinical trials (early-phase clinical trials (EPCT)). In this study, associations between objective smartphone measurements of physical activity and fitness and early trial discontinuation in patients with cancer participating in EPCT were investigated.MethodsBefore start of treatment, physical activity (steps/day) and physical fitness (meters walked in 6 min) were measured with a smartphone, and patient-reported physical function (PRO-PF) was assessed (EORTC QLQ-C30-PF). Early trial discontinuation was defined as discontinuation ≤ 28 days. Univariable logistic regression analyses were performed to study associations of physical activity, fitness, and function with early trial discontinuation. Optimal cutoff values of physical activity and fitness were assessed with ROCs, based on positive predictive values (PPV).ResultsMedian (interquartile range (IQR)) step count was 4263 (2548–6897) steps/day, mean ± standard deviation 6-min walking distance was 477 ± 120 m and median (IQR) PRO-PF score was 83 (67–95) points. Fourteen patients (12%) discontinued the trial early. Smartphone measurements of physical activity in units of 100 steps per day (odds ratio (OR) = 0.96, 95% CI = 0.94–0.99, p = 0.01), physical fitness (OR = 0.99, 95% CI = 0.98–0.99, p < 0.01), and PRO-PF (OR = 0.97, 95% CI = 0.94–1.00, p = 0.03) were associated with early trial discontinuation. Optimal cutoff values were < 900 steps for physical activity and < 285 m for physical fitness. PPV for early trial discontinuation was 100% in patients who walked both < 1500 steps per day and < 300 m in 6 min.ConclusionsObjective smartphone measurements of physical activity and fitness are associated with early trial discontinuation. However, cutoff values should be externally validated in a larger cohort before implementation in clinical practice.
Highlights
We found that objective smartphone measurements of step count are feasible, valid, and reliable in patients with cancer [15]
Acceptability, feasibility, and usability of smartphone measurements of physical activity and fitness in clinical practice were evaluated. This is an observational study for patients with advanced cancer referred for participation in EPCT to determine whether objective smartphone measurements of physical activity and fitness are associated with early trial discontinuation
The rate of early trial discontinuation was significantly different with respect to performance status, 4% in patients with a performance score (PS) of 0 and 18% in patients with a PS > 0 (p = 0.02)
Summary
Phase I clinical trials establish the maximal tolerated dosage of a possible effective anti-cancer drug [1]. This recommended dose can subsequently be used in phase II and III trials to investigate effectiveness of the drug [2]. To be eligible for participation in EPCT, patients must have an adequate performance status and organ function, and a minimal life expectancy of 3 months without treatment [2,3,4] By applying these rigorous inclusion criteria, potential harm of study treatment could be minimized while supporting optimal evaluation of the novel treatment strategy. Associations between objective smartphone measurements of physical activity and fitness and early trial discontinuation in patients with cancer participating in EPCT were investigated
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