Active Not Recruiting NCT05038254

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

Conditions: Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage IVB Gastric Cancer AJCC v8, Metastatic Colon Carcinoma, Metastatic Esophageal Carcinoma, Metastatic Gastric Carcinoma, Metastatic Liver Carcinoma, Metastatic Malignant Digestive System Neoplasm, Metastatic Malignant Small Intestinal Neoplasm, Metastatic Malignant Thoracic Neoplasm, Metastatic Pancreatic Carcinoma, Metastatic Rectal Carcinoma, Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage IV Gastric Cancer AJCC v8, Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8, Postneoadjuvant Therapy Stage IV Esophageal Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8, Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8, Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8, Stage IV Colon Cancer AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Rectal Cancer AJCC v8, Stage IV Small Intestinal, Esophageal, Colorectal, Mesenteric, and Peritoneal Gastrointestinal Stromal Tumor AJCC v8, Stage IVA Colon Cancer AJCC v8, Stage IVA Hepatocellular Carcinoma AJCC v8, Stage IVA Rectal Cancer AJCC v8, Stage IVB Colon Cancer AJCC v8, Stage IVB Hepatocellular Carcinoma AJCC v8, Stage IVB Rectal Cancer AJCC v8, Stage IVC Colon Cancer AJCC v8, Stage IVC Rectal Cancer AJCC v8

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: NA

Enrollment: 750

Sponsor: M.D. Anderson Cancer Center

Location: M D Anderson Cancer Center Houston Texas

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Adults (≥ 18 years) * English- and Spanish-fluent participants with thoracic and/or gastrointestinal cancers who are scheduled to initiate or continue outpatient chemotherapy at either MDACC (Texas Medical Center campus and any Houston-area location) or MDACC oncology clinic at Lyndon B Johnson (LBJ) hospital * Their adult (≥18 years) patient-identified or self-identified primary caregivers (MDACC only) * Participants on combination chemotherapy and immunotherapy or combination chemotherapy and biologic will also be eligible for inclusion. * Participants may participate if they do not have a caregiver, or if their caregiver declines participation; however, caregivers of MDACC participants may participate only if the participant consents. Exclusion Criteria: * Participants who are receiving investigational new drug treatments or concurrently enrolled in a phase 1 clinical trial will be excluded due to the associated structured reporting and regulatory requirements. * Participants with a requirement for inpatient infusion (i.e. CAR-T cell therapy), living in institutional settings (i.e. prison, nursing homes), with a history of dementia, physical disability or neurological deficits that prohibit ability to report symptom burden will also be excluded.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05038254). StuddyBuddy aggregates publicly available trial information.