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

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.

Screening Tool Identifies Older Adults With Cancer at Risk for Poor Outcomes.

BACKGROUND: Oncologists often struggle with managing the complex issues unique to older adults with cancer, and research is needed to identify patients at risk for poor outcomes. METHODS: This study enrolled patients aged ≥70 years within 8 weeks of a diagnosis of incurable gastrointestinal cancer. Patient-reported surveys were used to assess vulnerability (Vulnerable Elders Survey [scores ≥3 indicate a positive screen for vulnerability]), quality of life (QoL; EORTC Quality of Life of Cancer Patients questionnaire [higher scores indicate better QoL]), and symptoms (Edmonton Symptom Assessment System [ESAS; higher scores indicate greater symptom burden] and Geriatric Depression Scale [higher scores indicate greater depression symptoms]). Unplanned hospital visits within 90 days of enrollment and overall survival were evaluated. We used regression models to examine associations among vulnerability, QoL, symptom burden, hospitalizations, and overall survival. RESULTS: Of 132 patients approached, 102 (77.3%) were enrolled (mean [M] ± SD age, 77.25 ± 5.75 years). Nearly half (45.1%) screened positive for vulnerability, and these patients were older (M, 79.45 vs 75.44 years; P=.001) and had more comorbid conditions (M, 2.13 vs 1.34; P=.017) compared with nonvulnerable patients. Vulnerable patients reported worse QoL across all domains (global QoL: M, 53.26 vs 66.82; P=.041; physical QoL: M, 58.95 vs 88.24; P<.001; role QoL: M, 53.99 vs 82.12; P=.001; emotional QoL: M, 73.19 vs 85.76; P=.007; cognitive QoL: M, 79.35 vs 92.73; P=.011; social QoL: M, 59.42 vs 82.42; P<.001), higher symptom burden (ESAS total: M, 31.05 vs 15.00; P<.001), and worse depression score (M, 4.74 vs 2.25; P<.001). Vulnerable patients had a higher risk of unplanned hospitalizations (hazard ratio, 2.38; 95% CI, 1.08-5.27; P=.032) and worse overall survival (hazard ratio, 2.26; 95% CI, 1.14-4.48; P=.020). CONCLUSIONS: Older adults with cancer who screen positive as vulnerable experience a higher symptom burden, greater healthcare use, and worse survival. Screening tools to identify vulnerable patients should be integrated into practice to guide clinical care.

Human iPSC-Derived Endothelial Cells and Microengineered Organ-Chip Enhance Neuronal Development.

Human stem cell-derived models of development and neurodegenerative diseases are challenged by cellular immaturity in vitro. Microengineered organ-on-chip (or Organ-Chip) systems are designed to emulate microvolume cytoarchitecture and enable co-culture of distinct cell types. Brain microvascular endothelial cells (BMECs) share common signaling pathways with neurons early in development, but their contribution to human neuronal maturation is largely unknown. To study this interaction and influence of microculture, we derived both spinal motor neurons and BMECs from human induced pluripotent stem cells and observed increased calcium transient function and Chip-specific gene expression in Organ-Chips compared with 96-well plates. Seeding BMECs in the Organ-Chip led to vascular-neural interaction and specific gene activation that further enhanced neuronal function and in vivo-like signatures. The results show that the vascular system has specific maturation effects on spinal cord neural tissue, and the use of Organ-Chips can move stem cell models closer to an in vivo condition.