In a report of secondary outcomes from a randomised clinical study of adults with metastatic cancer, use of weekly electronic patient-reported outcome (PRO) surveys to monitor symptoms, compared with usual care, resulted in statistically significant improvements in physical function, symptom control, and health-related quality of life (HRQoL) at 3 months, with mean improvements of approximately 2.5 points on a 0- to 100-point scale. However, these findings should be interpreted provisionally pending results of the primary outcome of overall survival (OS) according to Dr. Ethan Basch of the Lineberger Comprehensive Cancer Center, University of North Carolina in Chapel Hill, NC, US and colleagues who published the findings from the PRO-TECT (Alliance AFT-39) cluster randomised study conducted in 52 US community oncology practices, on 5 June 2022 in JAMA.
The authors wrote in the background that patients with cancer frequently experience symptoms related to disease and treatment; however, symptoms during treatment are frequently undetected and untreated. Interventions that detect and treat symptoms may improve outcomes. Symptom monitoring using electronic systems that facilitate PRO surveys via the internet, mobile applications, or automated telephone interfaces have been shown to be feasible for identifying symptoms that can be treated by clinicians. Prior studies have reported improved outcomes for physical function, symptom control, HRQoL, hospitalisations, and survival when such electronic systems are used by patients receiving cancer treatment.
Based on findings from a prior single-centre study, a multicenter randomised clinical study, the PRO-TECT (Alliance AFT-39), was conducted across 52 US-based community oncology practices to determine whether electronic monitoring of symptoms by patients undergoing treatment for metastatic cancer improves survival, QoL outcomes, andother outcomes compared with usual care. In the report published in JAMA, the QoL secondary outcomes and selected exploratory outcomes are presented. Analysis of the study primary outcome, OS, requires national administrative data that are not yet available.
Patients were randomised to electronic symptom monitoring with PRO surveys or usual care. Between October 2017 and March 2020, 1191 adults being treated for metastatic cancer were enroled, with last follow-up on 17 May 2021. In the PRO group, 593 participants were asked to complete weekly surveys via an internet-based or automated telephone system for up to 1 year. Severe or worsening symptoms triggered care team alerts. The control group of 598 participants received usual care. The 3 prespecified secondary outcomes were physical function, symptom control, and HRQoL at 3 months, measured by the EORTC QLQ-C30 with range, 0-100 points; minimum clinically important difference (MCID), 2-7 for physical function; no MCID defined for symptom control or HRQoL.
Mean age of included participants was 62.2 years; 694 (58.3%) were women, and 1066 (89.5%) completed 3-month follow-up. Compared with usual care, mean changes on the QLQ-C30 from baseline to 3 months were significantly improved in the PRO group for physical function from 74.27 to 75.81 points while in control from 73.54 to 72.61 points with mean difference of 2.47 (95% confidence interval [CI] 0.41-4.53]; p = 0.02), as well as for symptom control in the PRO group from 77.67 to 80.03 points while in control from 76.75 to 76.55 points with mean difference of 2.56 (95% CI 0.95-4.17; p = 0.002), and HRQoL in the PRO group from 78.11 to 80.03 points while in control from 77.00 to 76.50 points with mean difference of 2.43 (95% CI 0.90-3.96; p = 0.002).
Patients in the PRO group had significantly greater odds of experiencing clinically meaningful benefits versus usual care for physical function, 7.7% more with improvements of at least 5 points and 6.1% fewer with worsening of at least 5 points, odds ratio (OR) 1.35 (95% CI 1.08-1.70; p = 0.009), for symptom control 8.6% and 7.5% (OR 1.50, 95% CI 1.15-1.95; p = 0.003), and for HRQoL 8.5% and 4.9% (OR 1.41, 95% CI 1.10-1.81; p = 0.006).
The authors commented that their study has several limitations besides the primary outcome of OS was not available at the time of the report. Benefits were not attained for all patients or all symptoms. It is likely related to heterogeneity of included patients. In the tests for interactions, some subgroups had small sample sizes, limiting statistical power to identify subgroups more likely to benefit from the intervention. Future studies can further identify populations most likely to benefit from the intervention. Surveys were only available in English, Spanish, and Mandarin. There was no attention control, and it is possible that the additional attention received by the intervention group, rather than the intervention components, explained the benefits reported. Furthermore, MCIDs are not established for the differences in response rates between groups. The study was not blinded, and the outcomes reported were patient reported. It is possible that awareness of group assignment contributed to differences between the two groups.
The authors concluded that in this report of secondary outcomes from a randomised clinical study of adults receiving cancer treatment, use of weekly electronic PRO surveys to monitor symptoms, compared with usual care, resulted in statistically significant improvements in physical function, symptom control, and HRQoL at 3 months, with mean improvements of approximately 2.5 points on a 0- to 100-point scale. These findings should be interpreted provisionally pending results of the primary outcome of OS.
Basch E, Schrag D, Henson S, et al. Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer A Randomized Clinical Trial. JAMA 2022;327(24):2413-2422.