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PURPOSE: We sought to determine the feasibility of delivering a Supportive Oncology Care at Home intervention among patients with pancreatic cancer. METHODS: We prospectively enrolled patients with pancreatic cancer from a parent trial of neoadjuvant fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFIRINOX). The intervention entailed (1) remote monitoring of patient-reported symptoms, vital signs, and body weight; (2) a hospital-at-home care model; and (3) structured communication with the oncology team. We defined the intervention as feasible if ≥ 60% of patients enrolled in the study and ≥ 60% completed the daily assessments within the first 2-weeks of enrollment. We determined rates of treatment delays, urgent clinic visits, emergency department visits, and hospitalizations among those who did (n = 20) and did not (n = 24) receive Supportive Oncology Care at Home from the parent trial. RESULTS: From January 2019 to September 2020, we enrolled 80.8% (21/26) of potentially eligible patients. One patient became ineligible following consent because of moving out of state, resulting in 20 participants (median age = 67 years). In the first 2 weeks of enrollment, 65.0% of participants completed all daily assessments. Overall, patients reported 96.1% of daily symptoms, 96.1% of daily vital signs, and 92.5% of weekly body weights. Patients receiving the intervention had lower rates of treatment delays (55.0% v 75.0%), urgent clinic visits (10.0% v 25.0%), and emergency department visits/hospitalizations (45.0% v 62.5%) compared with those not receiving the intervention from the same parent trial. CONCLUSION: Findings demonstrate the feasibility and acceptability of a Supportive Oncology Care at Home intervention. Future work will investigate the efficacy of this intervention for decreasing health care use and improving patient outcomes.
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Neoplasias Pancreáticas , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Fluorouracilo/efectos adversos , Humanos , Irinotecán/efectos adversos , Leucovorina/efectos adversos , Oxaliplatino/efectos adversos , Neoplasias Pancreáticas/tratamiento farmacológico , Neoplasias Pancreáticas/terapia , Neoplasias PancreáticasRESUMEN
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.
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Hospitalización , Neoplasias , Adulto , Ansiedad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/terapia , AutoinformeRESUMEN
BACKGROUND: Hospitalized patients with cancer often experience a high symptom burden, which may impact care satisfaction and healthcare utilization. METHODS: We prospectively enrolled patients with cancer and unplanned hospitalizations from September 2014 to April 2017. Upon admission, we assessed patients' care satisfaction (FAMCARE items: satisfaction with care coordination and speed with which symptoms are treated) and physical (Edmonton Symptom Assessment System [ESAS]) and psychological (Patient Health Questionnaire-4 [PHQ-4]) symptoms. We used regression models to identify factors associated with care satisfaction and associations of satisfaction with symptom burden and hospital length of stay (LOS). RESULTS: Among 1,576 participants, most reported being "satisfied"/ "very satisfied" with care coordination (90%) and speed with which symptoms are treated (89%). Older age (coordination: B < 0.01, P = 0.02, speed: B = 0.01, P < 0.01) and admission to a dedicated oncology service (B = 0.20, P < 0.01 for each) were associated with higher satisfaction. Higher satisfaction with care coordination was associated with lower ESAS-physical (B = - 1.28, P < 0.01), ESAS-total (B = - 2.73, P < 0.01), PHQ4-depression (B = - 0.14, P = 0.02), and PHQ4-anxiety (B = - 0.16, P < 0.01) symptoms. Higher satisfaction with speed with which symptoms are treated was associated with lower ESAS-physical (B = - 1.32, P < 0.01), ESAS-total (B = - 2.46, P < 0.01), PHQ4-depression (B = - 0.14, P = 0.01), and PHQ4-anxiety (B = - 0.17, P < 0.01) symptoms. Satisfaction with care coordination (B = - 0.48, P = 0.04) and speed with which symptoms are treated (B = - 0.44, P = 0.04) correlated with shorter LOS. CONCLUSIONS: Hospitalized patients with cancer report high care satisfaction, which correlates with older age and admission to a dedicated oncology service. Significant associations among higher care satisfaction, lower symptom burden, and shorter hospital LOS highlight the importance of improving symptom management and care coordination in this population.
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Neoplasias , Satisfacción Personal , Humanos , Neoplasias/epidemiología , Cuidados Paliativos , Medición de Resultados Informados por el Paciente , Satisfacción del Paciente , Evaluación de SíntomasRESUMEN
PURPOSE: Preoperative therapy for pancreatic cancer represents a new treatment option with the potential to improve outcomes for patients, yet with complex risks. By not discussing the potential risks and benefits of new treatment options, clinicians may hinder patients from making informed decisions. METHODS: From 2017 to 2019, we conducted a mixed-methods study. First, we elicited clinicians' (n = 13 medical, radiation, and surgery clinicians), patients' (n = 18), and caregivers' (n = 14) perceptions of information needed for decision making regarding preoperative therapy and generated a list of key elements. Next, we audio-recorded patients' (n = 20) initial multidisciplinary oncology visits and used qualitative content analyses to describe how clinicians discussed this information and surveyed patients to ask if they heard each key element. RESULTS: We identified 13 key elements of information patients need when making decisions regarding preoperative therapy, including treatment complications, alternatives, logistics, and potential outcomes. Patients reported hearing infrequently about complications (eg, hospitalizations [n = 3 of 20]) and alternatives (n = 8 of 20) but frequently recalled logistics and potential outcomes (eg, likelihood of surgery [n = 19 of 20]). Clinicians infrequently discussed complications (eg, hospitalizations [n = 7 of 20]), but frequently discussed alternatives, logistics, and potential outcomes (eg, likelihood of surgery [n = 20 of 20]). No overarching differences in clinician discussion content emerged to explain why patients did or did not hear about each key element. CONCLUSION: We identified key elements of information patients with pancreatic cancer need when considering preoperative therapy. Patients infrequently heard about treatment complications and alternatives, while frequently hearing about logistics and potential outcomes, underscoring areas for improvement in educating patients about new treatment options in oncology.
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Oncología Médica , Neoplasias Pancreáticas , Cuidadores , Toma de Decisiones , Humanos , Neoplasias Pancreáticas/cirugía , Encuestas y Cuestionarios , Neoplasias PancreáticasRESUMEN
BACKGROUND: Low muscle mass (quantity) is common in patients with advanced cancer, but little is known about muscle radiodensity (quality). We sought to describe the associations of muscle mass and radiodensity with symptom burden, healthcare use, and survival in hospitalized patients with advanced cancer. METHODS: We prospectively enrolled hospitalized patients with advanced cancer from September 2014 through May 2016. Upon admission, patients reported their physical (Edmonton Symptom Assessment System [ESAS]) and psychological (Patient Health Questionnaire-4 [PHQ-4]) symptoms. We used CT scans performed per routine care within 45 days before enrollment to evaluate muscle mass and radiodensity. We used regression models to examine associations of muscle mass and radiodensity with patients' symptom burden, healthcare use (hospital length of stay and readmissions), and survival. RESULTS: Of 1,121 patients enrolled, 677 had evaluable muscle data on CT (mean age, 62.86 ± 12.95 years; 51.1% female). Older age and female sex were associated with lower muscle mass (age: B, -0.16; P<.001; female: B, -6.89; P<.001) and radiodensity (age: B, -0.33; P<.001; female: B, -1.66; P=.014), and higher BMI was associated with higher muscle mass (B, 0.58; P<.001) and lower radiodensity (B, -0.61; P<.001). Higher muscle mass was significantly associated with improved survival (hazard ratio, 0.97; P<.001). Notably, higher muscle radiodensity was significantly associated with lower ESAS-Physical (B, -0.17; P=.016), ESAS-Total (B, -0.29; P=.002), PHQ-4-Depression (B, -0.03; P=.006), and PHQ-4-Anxiety (B, -0.03; P=.008) symptoms, as well as decreased hospital length of stay (B, -0.07; P=.005), risk of readmission or death in 90 days (odds ratio, 0.97; P<.001), and improved survival (hazard ratio, 0.97; P<.001). CONCLUSIONS: Although muscle mass (quantity) only correlated with survival, we found that muscle radiodensity (quality) was associated with patients' symptoms, healthcare use, and survival. These findings underscore the added importance of assessing muscle quality when seeking to address adverse muscle changes in oncology.