Harnessing Electronic Patient-Reported Outcomes (ePRO) in Routine Care to Promote Clinical Trial Enrollment: A Randomized Study

Abstract

Only approximately 5% of adult cancer patients participate in clinical trials. While collection of patient-reported outcomes (PRO) is now routine in clinical trials, their role in actively improving care is evolving, particularly in radiation oncology. At our single multi-site institution, weekly electronic patient reported outcomes (ePRO) questionnaires regarding acute toxicity are routinely sent to all patients undergoing breast radiation We hypothesized that using ePROs to prompt recruitment to a clinical trial assessing a supportive intervention would increase enrollment. An automated weekly query of ePRO survey responses was generated to identify patients with moderate or greater fatigue, the primary eligibility criterion for an ongoing randomized clinical trial testing an integrative medicine intervention. 23 radiation oncologists treating breast cancer were randomized to have their patients potentially eligible by ePRO receive a direct portal message about the trial, or to usual care (physician-based referral). Physician randomization was stratified by patient caseload and assigned in a 1:1 ratio. Secondarily, every other patient in the portal message group was assigned to receive the message either from their radiation oncologist or integrative medicine. Statistical analysis included two-sample, two-sided proportion tests. From September 5, 2022, to December 19, 2022, among 776 patients completing ePROs during radiation treatment, 252 patients (32%) screened positive for fatigue. Of those who screened positive, 135 were randomized to the ePRO-prompted portal message group and 117 to the usual care group (physician-based referral). Among patients in the portal message group, 52 responded (39%) and 27 enrolled (20%), compared to 1 patient referred (0.8%) and 0 enrolled with physician-based referral alone (p < 0.001). In the portal message group, there were 21 responses (30%) and 12 enrollments (17%) among those messaged by their radiation oncologist, compared to 31 responses (48%) and 15 enrollments (23%) among those messaged by integrative medicine. When evaluating the source of the portal message, there was a significant difference in response rate favoring integrative medicine (p = 0.03), but no difference in enrollments (p = 0.39). Utilization of ePROs to prompt recruitment to a trial testing a symptom intervention resulted in increased enrollment compared to standard physician-based referral, suggesting a promising new role for ePROs. Importantly, messaging from the supportive care service directly did not result in a difference in enrollments and may help reduce oncology physician-level barriers to studies testing supportive interventions. Future directions should investigate this method to reduce disparities in patients enrolling on clinical trials and facilitate access to symptom support services in routine cancer care.