Effects of exercise in breast cancer patients: implications of the trials within cohorts (TwiCs) design in the UMBRELLA Fit trial.

Autor: Gal R; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA, Utrecht, the Netherlands., Monninkhof EM; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA, Utrecht, the Netherlands., van Gils CH; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA, Utrecht, the Netherlands., Groenwold RHH; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands., Elias SG; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA, Utrecht, the Netherlands., van den Bongard DHJG; Department of Radiation Oncology, Amsterdam University Medical Centers, Amsterdam, The Netherlands., Peeters PHM; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA, Utrecht, the Netherlands., Verkooijen HM; Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands., May AM; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA, Utrecht, the Netherlands. A.M.May@umcutrecht.nl.
Jazyk: angličtina
Zdroj: Breast cancer research and treatment [Breast Cancer Res Treat] 2021 Nov; Vol. 190 (1), pp. 89-101. Date of Electronic Publication: 2021 Aug 24.
DOI: 10.1007/s10549-021-06363-9
Abstrakt: Purpose: The Trials within Cohorts (TwiCs) design aims to overcome problems faced in conventional RCTs. We evaluated the TwiCs design when estimating the effect of exercise on quality of life (QoL) and fatigue in inactive breast cancer survivors.
Methods: UMBRELLA Fit was conducted within the prospective UMBRELLA breast cancer cohort. Patients provided consent for future randomization at cohort entry. We randomized inactive patients 12-18 months after cohort enrollment. The intervention group (n = 130) was offered a 12-week supervised exercise intervention. The control group (n = 130) was not informed and received usual care. Six-month exercise effects on QoL and fatigue as measured in the cohort were analyzed with intention-to-treat (ITT), instrumental variable (IV), and propensity scores (PS) analyses.
Results: Fifty-two percent (n = 68) of inactive patients accepted the intervention. Physical activity increased in patients in the intervention group, but not in the control group. We found no benefit of exercise for dimensions of QoL (ITT difference global QoL: 0.8, 95% CI = - 2.2; 3.8) and fatigue, except for a small beneficial effect on physical fatigue (ITT difference: - 1.1, 95% CI = - 1.8; - 0.3; IV: - 1.9, 95% CI = - 3.3; - 0.5, PS: - 1.2, 95% CI = - 2.3; - 0.2).
Conclusion: TwiCs gave insight into exercise intervention acceptance: about half of inactive breast cancer survivors accepted the offer and increased physical activity levels. The offer resulted in no improvement on QoL, and a small beneficial effect on physical fatigue.
Trial Registration: Netherlands Trial Register (NTR5482/NL.52062.041.15), date of registration: December 07, 2015.
(© 2021. The Author(s).)
Databáze: MEDLINE
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