2030O - Remote symptom monitoring with electronic patient-reported outcomes (ePROs) during treatment for metastatic cancer: Results from the PRO-TECT trial (Alliance AFT-39)

Background

During cancer treatment, symptoms are common but often go undetected by clinicians. Remote monitoring with ePROs can detect symptoms early and alert clinicians to intervene, thereby relieving suffering and avoiding complications.

Methods

PRO-TECT was a cluster-randomized trial in 52 US oncology practices. Practices were assigned 1:1 to remote monitoring with ePRO surveys, or usual care. At ePRO practices, patients receiving treatment for metastatic cancer were invited to complete a weekly survey by web or automated telephone system for up to 1 year or until discontinuation of cancer treatment. The survey included 9 PRO-CTCAE symptoms, performance status, and falls. Severe/worsening symptoms generated electronic alerts to nurses, and symptom reports were available to clinicians at visits. Here we report the primary outcome of overall survival after 24 months of follow up, compared between groups using Cox regression incorporating clustering and disease covariates. Other outcomes included mean emergency department (ED) or hospital visits based on chart abstraction and proportion of patients with clinically meaningful benefit in symptoms (EORTC QLQ-C30) at 3 months, compared using mixed modeling and cumulative logistic regression. We previously reported significant benefits in health-related quality of life and physical function ( JAMA 2022 ;327:2413-22).

Results

1191 patients were enrolled 10/2017-03/2020 (593 PRO; 598 usual care). No difference was seen in survival between groups (HR 0.99; p=0.86). The mean number of ED or hospital visits was lower in the ePRO group vs. usual care (1.48 vs 1.81; p=0.006). A greater proportion of patients in the ePRO group experienced benefits in fatigue (OR 1.77; p<0.001), anorexia (OR 1.32; p=0.03), nausea/vomiting (OR 1.40; p=0.01), and sleep (OR 1.73; p<0.001). Patients completed 20,565/22,486 (91.5%) of expected weekly ePRO surveys.

Conclusions

Remote monitoring with ePROs during cancer treatment did not impact survival, but reduced visits to the ED or hospital, and conferred benefits on function and symptoms. Conduct of this trial during the pandemic amidst nursing shortages may have reduced efficacy of the intervention.

Clinical trial identification

NCT03249090.

Editorial acknowledgement

Legal entity responsible for the study

Alliance Foundation Trials.

Funding

Patient-Centered Outcomes Research Institute (PCORI) award No. IHS-1511-33392.

Disclosure

E. Basch: Financial Interests, Personal, Advisory Role: Resilience Health, Sivan Health, Navigating Cancer, AstraZeneca. D. Schrag, P.A. Spears: Financial Interests, Personal, Advisory Role: Pfizer. C. Snyder: Financial Interests, Institutional, Principal Investigator: Pfizer, Genentech; Financial Interests, Personal, Advisory Role: Janssen. D. Bruner: Financial Interests, Personal, Advisory Role: Flatiron. V. Blinder: Financial Interests, Personal, Advisory Role: Carevive Systems. A. Weiss: Financial Interests, Institutional, Research Funding: Myriad Laboratories. All other authors have declared no conflicts of interest.