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Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events

ABSTRACT: This clinical trial studies if enhanced outpatient symptom management with telemedicine and remote monitoring can help reduce acute care visit due to chemotherapy-related adverse events. Receiving telemedicine and remote monitoring may help patients have better outcomes (such as fewer avoidable emergency room visits and hospitalizations, better quality of life, fewer symptoms, and fewer treatment delays) than patients who receive usual care.

DISEASE(S): Adenocarcinoma,Clinical Stage Ivb Gastric Cancer Ajcc V8,Carcinoma,Pathologic Stage Iva Esophageal Squamous Cell Carcinoma Ajcc V8,Metastatic Malignant Digestive System Neoplasm,Neoplasms,Pathologic Stage Ivb Esophageal Squamous Cell Carcinoma Ajcc V8,Pathologic Stage Iv Esophageal Squamous Cell Carcinoma Ajcc V8,Esophageal Neoplasms,Pathologic Stage Ivb Esophageal Adenocarcinoma Ajcc V8,Stage Iv Colon Cancer Ajcc V8,Metastatic Malignant Small Intestinal Neoplasm,Stage Ivc Colon Cancer Ajcc V8,Stomach Neoplasms,Esophageal Squamous Cell Carcinoma,Clinical Stage Iv Gastric Cancer Ajcc V8,Postneoadjuvant Therapy Stage Ivb Esophageal Adenocarcinoma Ajcc V8,Postneoadjuvant Therapy Stage Ivb Esophageal Squamous Cell Carcinoma Ajcc V8,Clinical Stage Iv Esophageal Adenocarcinoma Ajcc V8,Metastatic Gastric Carcinoma,Carcinoma, Squamous Cell,Clinical Stage Ivb Esophageal Adenocarcinoma Ajcc V8,Stage Ivb Colon Cancer Ajcc V8,Rectal Neoplasms,Metastatic Pancreatic Carcinoma,Stage Iva Hepatocellular Carcinoma Ajcc V8,Carcinoma, Hepatocellular,Intestinal Neoplasms,Clinical Stage Iva Esophageal Squamous Cell Carcinoma Ajcc V8,Postneoadjuvant Therapy Stage Iv Esophageal Squamous Cell Carcinoma Ajcc V8,Metastatic Esophageal Carcinoma,Postneoadjuvant Therapy Stage Iv Gastric Cancer Ajcc V8,Stage Ivb Rectal Cancer Ajcc V8,Gastrointestinal Neoplasms,Stage Iv Rectal Cancer Ajcc V8,Clinical Stage Iva Esophageal Adenocarcinoma Ajcc V8,Metastatic Rectal Carcinoma,Stage Iv Small Intestinal, Esophageal, Colorectal, Mesenteric, And Peritoneal Gastrointestinal Stromal Tumor Ajcc V8,Postneoadjuvant Therapy Stage Iva Esophageal Adenocarcinoma Ajcc V8,Stage Ivc Rectal Cancer Ajcc V8,Postneoadjuvant Therapy Stage Iv Esophageal Adenocarcinoma Ajcc V8,Thoracic Neoplasms,Stage Iva Colon Cancer Ajcc V8,Metastatic Colon Carcinoma,Stage Iv Pancreatic Cancer Ajcc V8,Pancreatic Neoplasms,Clinical Stage Iva Gastric Cancer Ajcc V8,Digestive System Neoplasms,Pathologic Stage Iva Esophageal Adenocarcinoma Ajcc V8,Pathologic Stage Iv Gastric Cancer Ajcc V8,Stage Iv Hepatocellular Carcinoma Ajcc V8,Clinical Stage Iv Esophageal Squamous Cell Carcinoma Ajcc V8,Stage Iva Rectal Cancer Ajcc V8,Postneoadjuvant Therapy Stage Iva Esophageal Squamous Cell Carcinoma Ajcc V8,Stage Ivb Hepatocellular Carcinoma Ajcc V8,Clinical Stage Ivb Esophageal Squamous Cell Carcinoma Ajcc V8,Metastatic Liver Carcinoma,Pathologic Stage Iv Esophageal Adenocarcinoma Ajcc V8,Metastatic Malignant Thoracic Neoplasm,Colonic Neoplasms,Gastrointestinal Stromal Tumors

PROVIDER: 2389176 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background: Identifying individuals at heightened cardiovascular risk is a priority for reducing the global burden of cardiovascular disease. Aspirin is widely used to prevent cardiovascular events, though with variable results. Therefore, we hypothesized that aspirin exposure would reveal novel biological pathways relevant to the development of cardiovascular events. Methods: We administered aspirin, followed by peripheral blood RNA microarray profiling, in a discovery cohort of healthy volunteers (n = 50, HV1), followed by two validation cohorts of healthy volunteers (n = 53, HV2) or outpatient cardiology (OPC, n = 25) patients, in conjunction with platelet function testing with the platelet functions score (PFS, HV1 and HV2) or the VerifyNow Asprin (VN, OPC) test. Sets of coexpressed genes, or “Factors” were identified via Bayesian sparse factor analysis and associated with platelet function in HV1 and validated in HV2 and OPC. Validated factors were associated with death/MI in observational (n = 191) and case:control (n = 447) patient cohorts with available RNA data collected at the time of cardiac catheterization. Results: Factor analysis yielded 20 Factors, of which one, Factor 14, contained 60 genes and was associated with PFS in HV1 (r = -0.31, p-value = 0.03). Factor 14 was associated with platelet function with the same strength and direction in HV2 (r = -0.34, p-value = 0.02) and OPC (one-sided p-value for aspirin resistant vs. aspirin sensitive = 0.046), thus validating the association. Factor 14 was associated with death/MI in the two patient cohorts, odds ratio (OR) = 1.2, 95% CI [1.02-1.4], p-value = 0.01 and hazard ratio = 1.5, [1.2-1.9], p = 0.001, respectively, independent of known cardiovascular risk factors (combined OR = 1.2, CI = [1.02, 1.4], p = 0.03). Factor 14 and the expression of the Factor 14 transcript most highly correlative of PFS, ITGA2B, improved reclassification compared to traditional risk factors (category-free net reclassification index = 31% and 37%, p ≤ 0.0002 for both). Conclusions: By challenging humans subjects with aspirin, a medication used for cardiovascular risk reduction, we elucidated genes and pathways that may underlie platelet function and mechanisms responsible for cardiovascular death/MI. This accession represents the OPC cohort microarray data

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Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events

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