Effect of a Symptom Monitoring Intervention for Patients Hospitalized With Advanced Cancer: A Randomized Clinical Trial

Abstract

Importance: Symptom monitoring interventions are increasingly becoming the standard of care in oncology, but studies assessing these interventions in the hospital setting are lacking.

Objective: To evaluate the effect of a symptom monitoring intervention on symptom burden and health care use among hospitalized patients with advanced cancer.

Design, setting, and participants: This nonblinded randomized clinical trial conducted from February 12, 2018, to October 30, 2019, assessed 321 hospitalized adult patients with advanced cancer and admitted to the inpatient oncology services of an academic hospital. Data obtained through November 13, 2020, were included in analyses, and all analyses assessed the intent-to-treat population.

Interventions: Patients in both the intervention and usual care groups reported their symptoms using the Edmonton Symptom Assessment System (ESAS) and the 4-item Patient Health Questionnaire-4 (PHQ-4) daily via tablet computers. Patients assigned to the intervention had their symptom reports displayed during daily oncology rounds, with alerts for moderate, severe, or worsening symptoms. Patients assigned to usual care did not have their symptom reports displayed to their clinical teams.

Main outcomes and measures: The primary outcome was the proportion of days with improved symptoms, and the secondary outcomes were hospital length of stay and readmission rates. Linear regression was used to evaluate differences in hospital length of stay. Competing-risk regression (with death treated as a competing event) was used to compare differences in time to first unplanned readmission within 30 days.

Results: From February 12, 2018, to October 30, 2019, 390 patients (76.2% enrollment rate) were randomized. Study analyses to assess change in symptom burden included 321 of 390 patients (82.3%) who had 2 or more days of symptom reports completed (usual care, 161 of 193; intervention, 160 of 197). Participants had a mean (SD) age of 63.6 (12.8) years and were mostly male (180; 56.1%), self-reported as White (291; 90.7%), and married (230; 71.7%). The most common cancer type was gastrointestinal (118 patients; 36.8%), followed by lung (60 patients; 18.7%), genitourinary (39 patients; 12.1%), and breast (29 patients; 9.0%). No significant differences were detected between the intervention and usual care for the proportion of days with improved ESAS-physical (unstandardized coefficient [B] = -0.02; 95% CI, -0.10 to 0.05; P = .56), ESAS-total (B = -0.05; 95% CI, -0.12 to 0.02; P = .17), PHQ-4-depression (B = -0.02; 95% CI, -0.08 to 0.04; P = .55), and PHQ-4-anxiety (B = -0.04; 95% CI, -0.10 to 0.03; P = .29) symptoms. Intervention patients also did not differ significantly from patients receiving usual care for the secondary end points of hospital length of stay (7.59 vs 7.47 days; B = 0.13; 95% CI, -1.04 to 1.29; P = .83) and 30-day readmission rates (26.5% vs 33.8%; hazard ratio, 0.73; 95% CI, 0.48-1.09; P = .12).

Conclusions and relevance: This randomized clinical trial found that for hospitalized patients with advanced cancer, the assessed symptom monitoring intervention did not have a significant effect on patients' symptom burden or health care use. These findings do not support the routine integration of this type of symptom monitoring intervention for hospitalized patients with advanced cancer.

Trial registration: ClinicalTrials.gov Identifier: NCT03396510.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Knight reported stock ownership in Agilent Technologies, Assembly Biosciences, Illumina, IQVIA, and Thermo Fisher Scientific outside the submitted work. Dr Ryan reported receiving grants from Stand Up To Cancer; equity from MPM Capital and Exact Sciences Equity; and personal fees from Boehringer Ingelheim, UpToDate, and McGraw Hill outside the submitted work. Dr Greer reported receiving grants and personal fees from Blue Note Therapeutics and royalties from Springer (Humana Press) outside the submitted work. Dr El-Jawahri reported consulting for Novartis, GlaxoSmithKline, and Aim Pathway outside the submitted work. Dr Temel reported receiving grants from AstraZeneca through funding from the National Comprehensive Cancer Network outside the submitted work. No other disclosures were reported.

Figures

Figure.. CONSORT Diagram