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

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

Non Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Description

PRIMARY OBJECTIVE:

I. Determine the efficacy of remote patient monitoring (RPM) on improving clinical outcomes.

SECONDARY OBJECTIVE:

I. Evaluate the following patient-centered outcomes: treatment delays, health-related quality-of-life (HRQOL), patient activation, and family caregiver-experience.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care consisting of oncology care provided via telemedicine.

ARM II: Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.

Eligibility

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.

Study details
    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

NCT05038254

M.D. Anderson Cancer Center

20 August 2025

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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