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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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Before start of treatment, physical activity (steps\/day) and physical fitness (meters walked in 6\u00a0min) 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 \u2264\u200928\u00a0days. 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).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Median (interquartile range (IQR)) step count was 4263 (2548\u20136897) steps\/day, mean \u00b1 standard deviation 6-min walking distance was 477\u2009\u00b1\u2009120\u00a0m and median (IQR) PRO-PF score was 83 (67\u201395) points. Fourteen patients (12%) discontinued the trial early. Smartphone measurements of physical activity in units of 100 steps per day (odds ratio (OR)\u2009=\u20090.96, 95% CI\u2009=\u20090.94\u20130.99, <jats:italic>p<\/jats:italic>\u2009=\u20090.01), physical fitness (OR\u2009=\u20090.99, 95% CI\u2009=\u20090.98\u20130.99, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.01), and PRO-PF (OR\u2009=\u20090.97, 95% CI\u2009=\u20090.94\u20131.00, <jats:italic>p<\/jats:italic>\u2009=\u20090.03) were associated with early trial discontinuation. Optimal cutoff values were &lt;\u2009900 steps for physical activity and &lt;\u2009285\u00a0m for physical fitness. PPV for early trial discontinuation was 100% in patients who walked both &lt;\u20091500 steps per day and &lt;\u2009300\u00a0m in 6\u00a0min.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Objective 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.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00520-020-05902-2","type":"journal-article","created":{"date-parts":[[2020,11,24]],"date-time":"2020-11-24T17:03:29Z","timestamp":1606237409000},"page":"3783-3792","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Smartphone measurements of physical activity and fitness are associated with early trial discontinuation of patients in (hemato)oncology phase I\/II clinical trials"],"prefix":"10.1007","volume":"29","author":[{"given":"Joeri A. 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