Smartphone measurements of physical activity and fitness are associated with early trial discontinuation of patients in (hemato)oncology phase I/II clinical trials

Autor: Myra E. van Linde, Mieke Alberts, Laurien M. Buffart, Sonja Zweegman, Henk M.W. Verheul, Niels C. W. J. van de Donk, Sandy Kruyswijk, Joeri A J Douma
Přispěvatelé: Internal medicine, Hematology, CCA - Cancer Treatment and quality of life
Rok vydání: 2020
Předmět:
Zdroj: Supportive Care in Cancer
Supportive Care in Cancer, 29(7), 3783-3792. Springer Verlag
Supportive Care in Cancer, 29, 3783-3792
Douma, J A J, Zweegman, S, Alberts, M, Kruyswijk, S, van de Donk, N C W J, van Linde, M, Buffart, L M & Verheul, H M W 2021, ' Smartphone measurements of physical activity and fitness are associated with early trial discontinuation of patients in (hemato)oncology phase I/II clinical trials ', Supportive Care in Cancer, vol. 29, no. 7, pp. 3783-3792 . https://doi.org/10.1007/s00520-020-05902-2
Supportive Care in Cancer, 29, 7, pp. 3783-3792
ISSN: 1433-7339
0941-4355
DOI: 10.1007/s00520-020-05902-2
Popis: Background Patients, 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. Methods Before 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). Results Median (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 p = 0.03) were associated with early trial discontinuation. Optimal cutoff values were Conclusions 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.
Databáze: OpenAIRE
Externí odkaz: