Overall survival analysis of eSyM: A cluster randomized trial of an electronic patient-reported outcomes (ePRO)-based symptom management program.

Abstract

11003 Background: ePRO monitoring can improve outcomes yet remains underutilized in routine cancer care. We conducted a pragmatic type II hybrid effectiveness–implementation trial using a cluster-randomized stepped-wedge design to assess an ePRO-based, EHR-integrated symptom management program (eSyM) across 6 health systems. Our prior analyses demonstrated that eSyM use, but not eSyM deployment, was associated with a significant reduction in emergency department visits and hospitalizations. Here, we report results of the overall survival (OS) analysis. Methods: Eligible patients were adults who received chemotherapy (CHEMO) or had surgery (SURG) for a gastrointestinal (GI), gynecologic (GYN), or thoracic (THOR) tumor from Jan 2018-Feb 2023. The outcome was OS 1 year after starting chemotherapy or postoperative discharge. The primary analysis compared patients treated pre- versus post-deployment of eSyM. A secondary analysis compared patients who were treated post-deployment and did versus did not use eSyM, where users were those who reported ePROs via eSyM at least once. Cox regression models accounted for sociodemographic, clinical, and health system factors. Analyses were stratified by treatment modality to account for heterogeneity of effect. Results: Health systems contributed data on 39,895 patients (selected characteristics in Table). After eSyM deployment, 45% of CHEMO and 53% of SURG patients used eSyM to report ePROs. Multivariable Cox regression analyses identified significant associations between eSyM deployment and OS for CHEMO (HR 1.11, 95%CI 1.03-1.21; P=0.007) and SURG (HR 0.86, 95% CI 0.76-0.98; P=0.026) patients. The adjusted absolute difference in 12-month OS probability for patients treated post-deployment vs. pre-deployment was -2.4% (P<.001) for CHEMO and 0.7% (P<0.031) for SURG. Comparing eSyM users vs. non-users from the post-deployment cohort only, OS was significantly better among CHEMO (HR 0.63, 95%CI 0.57-0.69; P<0.001; 12m OS diff 10.2%) and SURG (HR 0.58, 95%CI 0.49-0.69; P<0.001; 12m OS diff 2.8%) patients. Conclusions: Deployment of eSyM was associated with statistically significant but clinically marginal differences in OS. After eSyM was deployed, use of ePROs was associated with statistically significant and potentially meaningful improvements in OS. Considering that ePRO monitoring with eSyM decreases the need for acute care and may be associated with longer survival, strategies to improve adoption and implementation of ePRO-based symptom management programs may be warranted. Clinical trial information: NCT03850912 . CHEMO SURG Pre Post Pre Post # Patients 5149 7030 15917 11799 Age (median) 66 67 61 63 Female 54% 54% 72% 69% Charlson comorbidity ≥2 8% 7% 6% 7% GI, GYN, THOR 49%, 16%, 35% 45%, 17%, 38% 41%, 37%, 22% 43%, 33%, 24% # Deaths 1098 2037 546 614 12-mo OS (adjusted) 72.7% 70.2% 94.7% 95.4% 12 mo OS (users, non-users) -- 76.8%, 66.6% -- 96.0%, 93.3%