1. A digital, decentralized trial of exercise therapy in patients with cancer
- Author
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Whitney P. Underwood, Meghan G. Michalski, Catherine P. Lee, Gina A. Fickera, Su S. Chun, Stefan E. Eng, Lydia Y. Liu, Brandon L. Tsai, Chaya S. Moskowitz, Jessica A. Lavery, Kimberly J. Van Zee, Ginger J. Gardner, Jennifer J. Mueller, Chau T. Dang, Behfar Ehdaie, Vincent P. Laudone, James A. Eastham, Jessica M. Scott, Paul C. Boutros, and Lee W. Jones
- Subjects
Computer applications to medicine. Medical informatics ,R858-859.7 - Abstract
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.
- Published
- 2024
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