A digital, decentralized trial of exercise therapy in patients with cancer
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.
Authors
- Kimberly J. Van Zee (ORCID: https://orcid.org/0000-0001-9550-4647)
- Brandon L. Tsai (ORCID: https://orcid.org/0000-0002-7372-3504)
- Paul C. Boutros (ORCID: https://orcid.org/0000-0003-0553-7520)
- Ginger J. Gardner (ORCID: https://orcid.org/0000-0003-3955-3238)
- Su S. Chun (ORCID: https://orcid.org/0000-0002-3684-4139)
- Jennifer J. Mueller (ORCID: https://orcid.org/0000-0003-0365-7510)
- Whitney P. Underwood (ORCID: https://orcid.org/0000-0001-5883-2860)
- Vincent P. Laudone (ORCID: https://orcid.org/0000-0001-9263-9415)
- Stefan E. Eng (ORCID: https://orcid.org/0000-0002-5245-6507)
- Catherine P. Lee (ORCID: https://orcid.org/0000-0002-8296-3876)
- Chau T. Dang (ORCID: https://orcid.org/0000-0001-5133-2265)
- Lee W. Jones (ORCID: https://orcid.org/0000-0002-3716-8793)
- Chaya S. Moskowitz (ORCID: https://orcid.org/0000-0002-2850-8450)
- Behfar Ehdaie
- Jessica M. Scott (ORCID: https://orcid.org/0000-0002-4845-5800)
- Gina A. Fickera
- Jessica A. Lavery (ORCID: https://orcid.org/0000-0002-2746-5647)
- Lydia Liu (ORCID: https://orcid.org/0000-0001-6026-3169)
- Meghan Michalski
- James A. Eastham
Institutions
- Memorial Sloan Kettering Cancer Center (US)
- University of California, Los Angeles (US)
- Cornell University (US)
Publication Details
- Journal
- npj Digital Medicine
- Published
- 2024-10-28
- DOI
- https://doi.org/10.1038/s41746-024-01288-1
- Citations
- 9
- Primary Topic
- Cancer survivorship and care
- Type
- article
- Field-Weighted Citation Impact
- 2.54
Funders
- Gateway for Cancer Research
- Memorial Sloan-Kettering Cancer Center
- National Cancer Institute