Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial

Abstract

Importance: Electronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene.

Objective: To evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes.

Design, setting, and participants: Report of secondary outcomes from the PRO-TECT (Alliance AFT-39) cluster randomized trial in 52 US community oncology practices randomized to electronic symptom monitoring with PRO surveys or usual care. Between October 2017 and March 2020, 1191 adults being treated for metastatic cancer were enrolled, with last follow-up on May 17, 2021.

Interventions: In the PRO group, participants (n = 593) 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 (n = 598) received usual care.

Main outcomes and measures: The 3 prespecified secondary outcomes were physical function, symptom control, and health-related quality of life (HRQOL) at 3 months, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30; range, 0-100 points; minimum clinically important difference [MCID], 2-7 for physical function; no MCID defined for symptom control or HRQOL). Results on the primary outcome, overall survival, are not yet available.

Results: Among 52 practices, 1191 patients were included (mean age, 62.2 years; 694 [58.3%] women); 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 (PRO, from 74.27 to 75.81 points; control, from 73.54 to 72.61 points; mean difference, 2.47 [95% CI, 0.41-4.53]; P = .02), symptom control (PRO, from 77.67 to 80.03 points; control, from 76.75 to 76.55 points; mean difference, 2.56 [95% CI, 0.95-4.17]; P = .002), and HRQOL (PRO, from 78.11 to 80.03 points; control, from 77.00 to 76.50 points; mean difference, 2.43 [95% CI, 0.90-3.96]; P = .002). Patients in the PRO group had significantly greater odds of experiencing clinically meaningful benefits vs usual care for physical function (7.7% more with improvements of ≥5 points and 6.1% fewer with worsening of ≥5 points; odds ratio [OR], 1.35 [95% CI, 1.08-1.70]; P = .009), symptom control (8.6% and 7.5%, respectively; OR, 1.50 [95% CI, 1.15-1.95]; P = .003), and HRQOL (8.5% and 4.9%, respectively; OR, 1.41 [95% CI, 1.10-1.81]; P = .006).

Conclusions and relevance: In this report of secondary outcomes from a randomized clinical trial 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 overall survival.

Trial registration: ClinicalTrials.gov Identifier: NCT03249090.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Basch reported receipt of personal fees from Navigating Cancer, Carevive Systems Inc, Sivan, AstraZeneca, Resilience, and the Research Triangle Institute for serving as a scientific advisor; receipt of research funding from the National Cancer Institute (NCI); being owner of Carolina Informatics; and employment by the University of North Carolina. Dr Schrag reported receipt of personal fees from Pfizer; nonfinancial support from Grail for serving as a site principal investigator; and grants from the American Association for Cancer Research awarded to Memorial Sloan Kettering Cancer Center. Dr Stover reported receipt of personal fees from Navigating Cancer and grants from Sivan and the Bladder Cancer Advocacy Network. Ms Spears reported receipt of personal fees from Pfizer. Dr Snyder reported receipt of grants from Genentech and Pfizer to Johns Hopkins and personal fees from Janssen via Health Outcomes Solutions. Dr Bruner reported receipt of personal fees from Wilmont Cancer Center, the NCI, and FlatIron and grants from the NCI Community Oncology Research Program and the Simons Foundation for Science Gallery Atlanta. Dr Samuel-Ryals reported receipt of grants from the NCI and having an uncompensated advisory role with Voluntis. Dr Weiss reported receipt of payments from Myriad Laboratories Incorporated for a research agreement. Dr Blinder reported receipt of compensation from Carevive Systems Inc. No other disclosures were reported.

Figures

Figure 1.. Participant Flow in the PRO-TECT Trial

PRO indicates patient-reported outcome; QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire. Patient cluster size: intervention group, mean, 22.8 (SD, 12.5) [range, 2-50]; control group, mean, 23.0 (SD, 8.6) [range, 3-42]. Rural/urban practice location (based on 2010 US Census data, confirmed with practice self-designation): intervention group, 7 rural (26.9%); 19 urban (73.1%); control group, 7 rural (26.9%); 19 urban (73.1%).

Figure 2.. Score Distribution and Model-Based Mean Change From Baseline at Each Assessment Time Point for Physical Function, Symptom Control, and Health-Related Quality of Life

Scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire. PRO indicates patient-reported outcome. Positive values represent improvement. In panels A-C, P values for model-based mean change from baseline at 1-, 3-, 6-, 9-, and 12-month assessments, respectively, are as follows: panel A (physical function), P = .21, P = .02, P = .003, P = .02, and P = .68; panel B (symptom control), P = .003, P = .002, P = .02, P = .045, and P = .32; and panel C (health-related quality of life), P = .003, P = .002, P = .006, P = .03, and P = .24. In panels D-F, circles indicate means; horizontal bars, medians; box tops and bottoms, IQRs; and whiskers, 1.5× the IQRs. See eTable 5 in Supplement 2 for point estimates and confidence intervals.

Figure 3.. Proportions of Patients Completing Expected Patient-Reported Outcome Surveys, Patients Remaining in the Study, and Completed Surveys at Each Week of Participation

The number of patients shown below the x-axis is the number of patients remaining in the study in that week.