Efficacy of digital therapeutics for perioperative management in patients with lung cancer: a randomized controlled trial.

Abstract

Background: Perioperative management and lung function recovery are vital for lung cancer patients. We conducted an open-label, single-center, noninferiority, randomized controlled trial in China to evaluate the efficacy of digital therapeutic (DTx)-assisted management vs. multidisciplinary management (MM) in the perioperative management of patients with lung cancer.

Methods: From July 2022 to June 2023, 186 minimally invasive lung surgery patients were randomized, and 147 completed the study. The participants were randomly assigned a 1:1 ratio to receive DTx-assisted management (n = 72) or traditional MM (n = 75). The primary endpoint was the pulmonary function recovery rate measured by forced expiratory volume in the first second (FEV1%) 3 weeks after surgery, and the noninferiority margin was set to 4.8%. The secondary endpoints included hospital stay duration, 90-day unplanned readmission rate, symptom scores, patient management time, and patient satisfaction rate. Exploratory endpoints include factors influencing postoperative lung function recovery.

Results: The lung function FEV1% recovery rate of the DTx group was not inferior to that of the MM group (87.18% ± 11.01% vs. 84.21% ± 11.75%). There were no significant differences between the two groups in terms of postoperative hospitalization duration or 90-day unplanned readmission rates. The patient management time in the DTx group was significantly shorter than that in the MM group (1.48 ± 3.22 min vs. 16.67 ± 6.41 min, P < 0.001). Patient symptom scores tended to decrease over time after discharge, and the 5 target symptoms included pain, coughing, shortness of breath, disturbed sleep, and fatigue. On the 7th day after discharge, the DTx group had a lower occurrence rate of the 5 target symptoms triggering the alert threshold compared to the MM group (P = 0.002). Patients with higher education levels achieved a better FEV1% recovery rate with DTx-assisted management (P = 0.021).

Conclusions: Compared with the MM group, the DTx group achieved noninferior results in all evaluated clinically meaningful endpoints but was significantly more efficient in perioperative management, providing an alternative digitalized management mode for patients with lung cancer surgery.

Trial registration: ChiCTR2200064723.