Abstract

We developed and evaluated the Digital Platform for Exercise (DPEx): a decentralized, patient-centric approach designed to enhance all aspects of clinical investigation of exercise therapy. DPEx integrated provision of a treadmill with telemedicine and remote biospecimen collection permitting all study procedures to be conducted in patient’s homes. Linked health biodevices enabled high-resolution monitoring of lifestyle and physiological response. Here we describe the rationale and development of DPEx as well as feasibility evaluation in three different cohorts of patients with cancer: a phase 0a development study among three women with post-treatment primary breast cancer; a phase 0b proof-of-concept trial of neoadjuvant exercise therapy in 13 patients with untreated solid tumors; and a phase 1a level-finding trial of neoadjuvant exercise therapy in 53 men with localized prostate cancer. Collectively, our study demonstrates the utility of a fully digital, decentralized approach to conduct clinical trials of exercise therapy in a clinical population.

Details

Title
A digital, decentralized trial of exercise therapy in patients with cancer
Author
Underwood, Whitney P. 1   VIAFID ORCID Logo  ; Michalski, Meghan G. 1 ; Lee, Catherine P. 1 ; Fickera, Gina A. 1 ; Chun, Su S. 1 ; Eng, Stefan E. 2   VIAFID ORCID Logo  ; Liu, Lydia Y. 2   VIAFID ORCID Logo  ; Tsai, Brandon L. 2   VIAFID ORCID Logo  ; Moskowitz, Chaya S. 1 ; Lavery, Jessica A. 1 ; Van Zee, Kimberly J. 1   VIAFID ORCID Logo  ; Gardner, Ginger J. 1 ; Mueller, Jennifer J. 1 ; Dang, Chau T. 1 ; Ehdaie, Behfar 1 ; Laudone, Vincent P. 1 ; Eastham, James A. 1 ; Scott, Jessica M. 3   VIAFID ORCID Logo  ; Boutros, Paul C. 2   VIAFID ORCID Logo  ; Jones, Lee W. 3   VIAFID ORCID Logo 

1  Memorial Sloan Kettering Cancer Center (MSK), New York, USA (GRID:grid.51462.34) (ISNI:0000 0001 2171 9952) 
2  Los Angeles, Department of Human Genetics, University of California, Los Angeles, USA (GRID:grid.19006.3e) (ISNI:0000 0000 9632 6718); Los Angeles, Institute for Precision Health, University of California, Los Angeles, USA (GRID:grid.19006.3e) (ISNI:0000 0000 9632 6718); Los Angeles, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, USA (GRID:grid.516076.3); Los Angeles, Department of Urology, University of California, Los Angeles, USA (GRID:grid.19006.3e) (ISNI:0000 0000 9632 6718) 
3  Memorial Sloan Kettering Cancer Center (MSK), New York, USA (GRID:grid.51462.34) (ISNI:0000 0001 2171 9952); Weill Cornell Medical College, New York, USA (GRID:grid.5386.8) (ISNI:000000041936877X) 
Pages
304
Publication year
2024
Publication date
Dec 2024
Publisher
Nature Publishing Group
e-ISSN
23986352
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1038/s41746-024-01288-1
ProQuest document ID
3121476797
Copyright
© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.