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A digital, decentralized trial of exercise therapy in patients with cancer.
- Underwood, Whitney;
- Michalski, Meghan;
- Lee, Catherine;
- Fickera, Gina;
- Chun, Su;
- Eng, Stefan;
- Liu, Lydia;
- Tsai, Brandon;
- Moskowitz, Chaya;
- Lavery, Jessica;
- Van Zee, Kimberly;
- Gardner, Ginger;
- Mueller, Jennifer;
- Dang, Chau;
- Ehdaie, Behfar;
- Laudone, Vincent;
- Eastham, James;
- Scott, Jessica;
- Boutros, Paul;
- Jones, Lee
- et al.
Published Web Location
https://doi.org/10.1038/s41746-024-01288-1Abstract
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 patients 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.
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