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

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.

Fig. 1. Digital Platform for Exercise (DPEx) Platform.

Summary of DPEx components and logistics.

Fig. 2. Phase 0b “proof of concept” trial.

a study schema and schedule of activities and b type and sampling frequency of assessments.

Fig. 3. Phase 0b “proof of concept” trial feasibility.

a geographical location of patients, b exercise therapy adherence and adherence with health device usage, c patient estimated time commitment versus matched site-based virtual twin, and d patient estimated cost versus matched site-based virtual twin. Box length and line indicates the median value. Each grey dot represents a single patient.

Fig. 4. Phase 1a dose-finding trial feasibility.

a geographical location of patients by exercise therapy dose level. Each dot represents a single patient. MSK logo depicts location of Memorial Sloan Kettering Cancer Center (MSK) main hospital (Upper East Side of Manhattan, New York City), b exercise therapy adherence and adherence with health device usage, c patient estimated time commitment versus matched site-based virtual twin, and d patient estimated cost versus matched site-based virtual twin. Box length and line indicates the median value. Each grey dot represents a single patient.