A digital therapeutic application (ePAL) to manage pain in patients with advanced cancer: A randomized controlled trial

Background Patients with advanced cancer often experience immense cancer pain that negatively impacts their quality of life. Interventions to address cancer-related pain are limited. Methods We conducted a randomized trial of a digital therapeutic app (ePAL) for patients with advanced cancer receiving care in a specialty palliative care clinic at a tertiary care hospital. Patients were randomized to ePAL or usual care. ePAL included 1) active pain monitoring; 2) artificial intelligence algorithm to triage patient symptoms; and 3) patient education to address barriers to pain management. Participants were instructed to use ePAL over 8 weeks. Patient-reported pain symptoms were assessed at baseline, week-4, and week-8 (primary endpoint) using the Brief Pain Inventory. Secondary outcomes include pain-related hospitalizations by week-8. Results We enrolled 112 patients who were randomly assigned to ePAL (N=56) or usual care (N=56). Patients utilized ePAL on average 2.1 times per week to report pain symptoms, and 47.6% reported their pain at least once per week over eight weeks. Patients randomized to ePAL reported lower pain scores at week-4 (mean: 3.16 vs. 4.28, P=0.010) and week-8 (mean:2.99 vs. 4.05, P=0.017), compared to those receiving usual care. Participants randomized to ePAL were less likely to experience a pain-related hospitalization compared to those in the usual care group (7.1% vs. 23.2% P=0.018) Conclusions ePAL was associated with lower patient-reported pain and fewer pain-related hospitalizations compared to usual care in patients with advanced cancer. This study demonstrates the promise of digital therapeutics for improving patients’ symptoms while reducing burdensome hospitalizations.