A digital, decentralized clinical trial (DPEx) has demonstrated the feasibility of remotely delivered and supervised exercise therapy for cancer patients. The study, published in Nature Digital Medicine, utilized wearable technology and video conferencing to monitor patients' adherence and safety during at-home exercise sessions. This innovative approach aims to overcome barriers to exercise, such as travel and time constraints, and improve access to personalized interventions for individuals undergoing cancer treatment.
DPEx Trial Design and Results
The DPEx platform was evaluated in three phases: a phase 0a development cohort, a phase 0b proof-of-concept trial, and a phase 1a exercise level-finding trial. The phase 0a cohort focused on establishing the logistics and core components of DPEx, recruiting three inactive women with post-treatment early-stage breast cancer. The phase 0b trial examined the application of DPEx in the pre-operative setting for patients with breast, endometrial, or prostate cancer. The phase 1a trial aimed to identify the recommended phase 2 dose for neoadjuvant exercise therapy in men with localized prostate cancer.
Exercise therapy consisted of individualized, supervised treadmill walking sessions, with intensity prescribed based on pre-exercise cardiorespiratory fitness tests. Study personnel monitored sessions remotely, ensuring patient safety and adherence. Wearable devices, including activity and heart rate monitors, blood pressure monitors, and body composition scales, provided real-time physiological data.
Key Findings and Implications
The results from the three trials indicate that DPEx can effectively deliver personalized exercise interventions and collect real-time physiological data. The decentralized approach reduced patient time commitment and costs compared to traditional site-based exercise programs. For example, the study estimated the total time commitment and cost for DPEx compared with a hypothetical, traditional site-based model at MSK Main Campus. The study found that DPEx reduced travel time and associated expenses for patients.
"This study demonstrates the potential of digital health technologies to improve access to exercise therapy for cancer patients," said lead author Dr. Lee W. Jones. "By leveraging wearable sensors and remote monitoring, we can deliver personalized interventions in the comfort of patients' homes, reducing barriers to participation and improving outcomes."
Safety and Feasibility
Safety was a primary consideration throughout the DPEx trials. Study personnel were trained to manage adverse events remotely, with clear protocols for escalating care when necessary. The study reported that adverse events were generally mild and manageable, with no serious adverse events related to the exercise interventions.
Feasibility was assessed by evaluating various factors, including patient accrual, adherence to exercise sessions, and adherence to health device use. The results showed high rates of patient engagement and adherence, indicating that the DPEx platform is user-friendly and acceptable to patients.
Future Directions
The DPEx platform holds promise for expanding access to exercise therapy for cancer patients, particularly those in underserved communities or with limited mobility. Future research will focus on evaluating the clinical effectiveness of DPEx in larger, randomized controlled trials. Additionally, researchers plan to explore the use of DPEx in other chronic disease populations.
"We are excited about the potential of DPEx to transform the delivery of exercise therapy and improve the lives of patients with cancer and other chronic conditions," said Dr. Jones. "By embracing digital health technologies, we can make personalized interventions more accessible and affordable, ultimately improving health outcomes for all."
