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

M.D. Anderson Cancer Center

Status: Active, not recruiting

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

Treatments: Other: Best Practice; Procedure: Patient Monitoring; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT05038254

NCI-2021-07464 (Registry Identifier)

2020-0702 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 3 patient groups

Arm I (standard of care)

Active Comparator group

Description:

Patients receive standard of care consisting of oncology care provided via telemedicine.

Treatment:

Other: Questionnaire Administration

Other: Best Practice

Arm II (standard of care, remote monitoring)

Experimental group

Description:

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

Treatment:

Other: Questionnaire Administration

Procedure: Patient Monitoring

Other: Best Practice

Arm III (standard of care, remote monitoring, biometrics)

Experimental group

Description:

Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring.

Treatment:

Other: Questionnaire Administration

Procedure: Patient Monitoring

Other: Best Practice