Convergence of Mobile Health Technology and Companion Care

Duke University is actively conducting a clinical trial (NCT06575712) to evaluate the efficacy of 'Step Up,' a hybrid digital therapeutics program for patients undergoing hematopoietic stem cell transplantation (HCT) and CAR-T cell therapy. This research is supported by an R01 research grant from the National Cancer Institute (NCI). The study goes beyond simple patient status monitoring by designing a multifaceted support model that combines in-person Coping Skills Training (CST) with Garmin wearable devices and a mobile application to promote real-time physical rehabilitation. With the rapid growth of the immune cell therapy market, there is a growing need for adjunctive digital healthcare technologies that not only improve patient survival rates but also substantially enhance their quality of life (QoL) after treatment.

Personalized Interventions Utilizing Digital Biomarkers

This clinical trial is designed for a total of 177 patients, comparing a control group that receives only standard treatment (Usual Care) with educational videos, and a 'Step Up' treatment group that receives real-time physiological data monitoring via a mobile app and wearable device through a randomized controlled trial. Patients in the 'Step Up' group will wear a Garmin Vivosmart 5 and have various digital biomarkers, such as heart rate, sleep patterns, and daily step count, measured in real-time and shared with healthcare professionals through a mobile app. By actively integrating digital biomarkers into the treatment process, this represents a significant paradigm shift in digital health platforms, transforming the previously discontinuous patient management into a 24/7 real-time monitoring system.

Synergy of Symptom Management and Physical Rehabilitation

The primary endpoint of the 'Step Up' program is designed to precisely measure the improvement in physical disability levels through changes in the physical well-being subscale score of the Functional Assessment of Cancer Therapy (FACT-G) scale and the measurement of the distance covered in the 6-minute walk test (6MWT), which assesses the patient's walking ability. Secondary endpoints include a comprehensive analysis of changes in fatigue, pain intensity, and psychological distress using the Patient-Reported Outcome Measurement Information System (PROMIS) from the National Institutes of Health (NIH), to analyze the correlation between symptom management and increased activity levels. This contributes to demonstrating the scientific mechanism by which the program not only alleviates pain but also enhances patients' self-efficacy in managing their symptoms, leading to actual physical rehabilitation.

Presenting a New Standard for Cancer Patient Support Care

With the global cancer patient support care market rapidly growing to approximately $29.9 billion by 2025, companies like Aptar Digital Health's 'Oleena' and Varian (under Siemens Healthineers) with 'Noona' are leading the market with remote patient monitoring platforms. This clinical study presents a differentiated non-pharmacological intervention that organically links professional occupational therapist (OT) coaching with patients' physiological data, unlike existing platforms that primarily focus on simple symptom recording and reporting. If significant data is obtained in the clinical trial, it will undoubtedly accelerate the standardization of digital therapeutics (DTx) prescriptions and insurance coverage, and serve as an important catalyst for transitioning the hospital-centric care model to a hybrid model centered on digital home care.