Abstract
Symptoms are often underdetected during cancer treatment. To determine if symptom monitoring with electronic patient-reported outcomes (PROs) improves clinical outcomes, we conducted a cluster-randomized trial in which 52 oncology practices were assigned to PRO or usual care. At PRO practices, patients with metastatic cancer were invited to complete weekly symptom surveys. Severe or worsening symptoms generated alerts to the care team. The primary outcome was overall survival, and secondary outcomes included emergency visits, time to deterioration of physical function, symptoms, health-related quality of life (HRQL) and patient satisfaction with PRO. Among 1,191 enrolled patients, there was no difference in survival (hazard ratio (HR) 0.99 (95% confidence interval (CI), 0.83-1.17); P = 0.86). Time to first emergency visit was significantly prolonged with PRO compared to usual care (HR 0.84 ((95% CI, 0.71-0.98); P = 0.03), with a 6.1% reduction in the cumulative incidence of emergency visits and fewer mean visits at 12 months with PRO (1.02 versus 1.30; P < 0.001). Benefits also significantly favored PRO for delayed deterioration of physical function (median 12.6 versus 8.5 months, HR 0.73; P = 0.002), symptoms (12.7 versus 9.9, HR 0.69; P < 0.001) and HRQL (15.6 versus 12.2, HR 0.72; P = 0.001), which remained significant when considering deaths in analyses. Most patients felt that PRO improved discussions with the care team (77.0% (188/244)), made them feel more in control of their care (84.0% (205/244)) and would recommend it to other patients (91.4% (223/244)). Patients completed 91.5% (20,565/22,486) of expected weekly symptom surveys. These findings demonstrate that symptom monitoring with PRO meaningfully improves clinical outcomes, the patient experience and utilization of services and should be included as a standard part of quality cancer clinical care. Future studies of PRO in clinical care should focus on these outcomes rather than mortality as primary endpoints. ClinicalTrials.gov registration: NCT03249090.