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

Study Overview

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

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.

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.

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

OTHER: Best Practice
PROCEDURE: Patient Monitoring
OTHER: Questionnaire Administration

2020-0702
NCI-2021-07464 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
2020-0702 (OTHER Identifier) (OTHER: M D Anderson Cancer Center)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-07-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-01-21
First Submitted that Met QC Criteria 2021-09-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-01-23
First Posted (ACTUAL) 2021-09-09	Results First Posted N/A	Last Verified 2025-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Health Services Research

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Arm I (standard of care) Patients receive standard of care consisting of oncology care provided via telemedicine.	OTHER: Best Practice Receive standard of care telemedicine OTHER: Questionnaire Administration Ancillary studies
EXPERIMENTAL: Arm II (standard of care, remote monitoring) Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.	OTHER: Best Practice Receive standard of care telemedicine PROCEDURE: Patient Monitoring Undergo remote monitoring OTHER: Questionnaire Administration Ancillary studies
EXPERIMENTAL: Arm III (standard of care, remote monitoring, biometrics) Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring.	OTHER: Best Practice Receive standard of care telemedicine PROCEDURE: Patient Monitoring Undergo remote monitoring OTHER: Questionnaire Administration Ancillary studies

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Arm I (standard of care)

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

OTHER: Best Practice

Receive standard of care telemedicine

OTHER: Questionnaire Administration

Ancillary studies

EXPERIMENTAL: Arm II (standard of care, remote monitoring)

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

OTHER: Best Practice

Receive standard of care telemedicine

PROCEDURE: Patient Monitoring

Undergo remote monitoring

OTHER: Questionnaire Administration

Ancillary studies

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

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

OTHER: Best Practice

Receive standard of care telemedicine

PROCEDURE: Patient Monitoring

Undergo remote monitoring

OTHER: Questionnaire Administration

Ancillary studies

Primary Outcome Measures	Measure Description	Time Frame
Rate of acute care visits	Defined as the proportion of unique oncology patients with emergency room visits or hospital admission over a 3-month period.	Up to 3 months

Secondary Outcome Measures	Measure Description	Time Frame
Change in health-related quality of life (HRQOL)	HRQOL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 version 2.1.	Baseline to 6 months
Change in patient engagement	Patient engagement will be evaluated with the 13-item Patient Activation Measure (PAM), which assesses knowledge, skill, and self-efficacy for self-management of health	Baseline to 6 months
Change in symptom management	Daily symptoms will be measured using the Common Terminology Criteria for Adverse Events version 5.	Baseline to 6 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Ryan W Huey, MD

Phone Number: 713-792-2828

Email: remotemonitoringprogram@mdanderson.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Ryan W Huey, MD, M.D. Anderson Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record