PRO-TECT Trial Shows That ePROs May Be Feasibly Implemented Into Routine Oncology Practice

Ethan Basch, MD, MSc

Leveraging electronic patient-reported outcomes (ePROs) may be a feasible, alternative approach to symptom monitoring in cancer care, according to findings from the PRO-TECT trial (NCT03249090), which were presented at the 2023 European Society of Medical Oncology Congress.

Key Findings

On average, the rate of weekly ePRO completion was 91.5%. This high number was likely because staff would call patients within 72 hours if they did not complete their survey online, according to investigators.

There was no significant difference between the 2 groups in terms of overall survival (OS; HR, 0.99; P = .96): the unadjusted estimated survival at 2 years was 42.0% (95% CI, 38.2%-46.2%) with the ePRO group vs 43.5% (95% CI, 39.7-47.6%) in the usual care group.

There was, however, a 6% reduction in emergency or hospital admission in the intervention arm. The mean number of admissions per patient over the course of 1 year was 1.48 with ePROs vs 1.81 with usual care (P = .006). In addition, the time to first emergency admission improved in the ePRO arm (HR, 0.84; P = .03).

There were also clinically meaningful and statistically significant improvements in physical functioning, symptom control, and quality of life in the intervention arms.

The PRO-TECT Trial

The PRO-TECT trial is a cluster, randomized trial assessing the utility or ePROs in the treatment of adult patients with advanced or metastatic cancer in community practices. It was conducted at 52 United States community oncology practices, across 25 states. Practices were assigned to either the intervention or control groups. Practices could enroll up to 50 patients who were not already on a therapeutic trial.

In the intervention, patients were asked to answer questions derived from the Common Terminology Criteria for Adverse Events (PRO-CTCAE) every week, either by web or an automated phone system. Nurses received an electronic notification if their patient’s condition worsened or if a new symptom arose.

Of note, many patients in this trial lived in rural areas and chose the telephone option. According to Ethan Basch, MD, MSc, this emphasizes the importance of meeting patients where they are at and choosing technology that is accessible.

The weekly PRO items queried about pain, nausea, vomiting, constipation, diarrhea, dyspnea, insomnia, depression, and oral intake, as well as falls, financial toxicity, and overall ECOG performance status.

As Basch, a medical oncologist with the UNC Lineberger Comprehensive Cancer Center, explained during the presentation, the current approach that most institutions have towards symptom monitoring is limited. When patients come in for an appointment, there are multiple hurdles that prevent effective communication. For example, the amount of time is limited, and it is possible that either the patient or provider may forget to discuss symptoms amid the other topics of discussion. When patients are home, they may be reluctant to reach out about their symptoms or even have problems connecting.

Digital symptom monitoring provides a unique alternative, as the e-reminder helps the patient overcome any hesitancy about reporting their symptoms. The e-alert allows the nursing staff to triage which patients need to come in for follow-up.

How Do Patients and Providers Perceive ePROS?

Previous reports from the PRO-TECT trial demonstrated that patients (n = 496) and nurses (n = 57) responded positively to the implementation of ePROs.

Most patients reported that the use of ePROs improved discourse with their providers (73%) and that it made them feel more in control of their own care (77%). Further, 89% of participants shared that they would recommend the system of ePROS to other patients.

Similarly, 79% of nurses responded that having the ePRO information helped them with clinical documentation, 84% of respondents said it helped increase the efficiency of their patient discussions, and 75% said it was useful in-patient care.

Of note, some nurses demonstrated hesitancy over this approach. Through qualitative interviews, it was revealed that about a quarter of nurse respondents were worried about the burden ePRO monitoring could add on to their preexisting workload.

Physicians reported positive experiences with the ePRO system; 91% said the information was useful, and 65% said the ePRO information helped guide patient discussions as well as treatment decision-making.

Overall, these findings were favorable and support the use of ePROs, Basch concluded.

“Although survival was not impacted in this trial, patients found the intervention to be valuable and experienced improved quality of life and decreased hospitalization,” he said. “Future ePRO implementations should use technologies that are easily accessible for patients, adjust nurse responsibilities to allow time for ePRO work and integrate ePROs into care processes.”

Reference

Basch E, Stover AM, Schrag D, et al. Clinical Utility and User Perceptions of a Digital System for Electronic Patient-Reported Symptom Monitoring During Routine Cancer Care: Findings From the PRO-TECT Trial. JCO Clin Cancer Inform. 2020;4:947-957. doi:10.1200/CCI.20.00081