npj Digital Medicine (Oct 2024)

A digital, decentralized trial of exercise therapy in patients with cancer

  • 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,
  • Lee W. Jones

DOI
https://doi.org/10.1038/s41746-024-01288-1
Journal volume & issue
Vol. 7, no. 1
pp. 1 – 13

Abstract

Read online

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.