Decline in Smartphone-Assessed Physical Activity Level is Associated With Clinical Outcomes in Phase I/II Clinical...

Area of Science:

• Oncology
• Digital Health
• Clinical Trials

Background:

• Physical function decline can predict cancer treatment complications.
• Objective smartphone measurements offer a feasible approach to assess physical function in cancer patients during early-phase clinical trials (EPCTs).

Purpose of the Study:

• To assess the feasibility of repeated smartphone measurements of physical activity and exercise capacity in cancer patients during EPCTs.
• To determine if declines in physical function are associated with clinical outcomes such as trial discontinuation and survival.

Main Methods:

• Patients' physical activity (steps/day) and exercise capacity (6-minute walk test [6MWT]) were measured using smartphones at baseline (T0), 4 weeks (T1), and 8 weeks (T2).
• Logistic regression and Cox proportional hazards models analyzed associations between physical function decline and trial discontinuation, progression-free survival (PFS), and overall survival (OS).

Main Results:

• Smartphone measurements were feasible, with high availability of step count and 6MWT data.
• Decline in step count was associated with higher odds of trial discontinuation at 8 weeks and 90 days.
• Step count decline significantly correlated with shorter PFS and OS.

Conclusions:

• Repeated smartphone measurements of physical activity are feasible in patients undergoing EPCTs.
• Physical activity decline is a significant predictor of trial discontinuation, PFS, and OS.
• Objective smartphone data can enhance cancer treatment development.