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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm I (standard of care)

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

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard of care telemedicine

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (standard of care, remote monitoring)

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

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Receive standard of care telemedicine

Patient Monitoring

Intervention Type PROCEDURE

Undergo remote monitoring

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Receive standard of care telemedicine

Patient Monitoring

Intervention Type PROCEDURE

Undergo remote monitoring

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive standard of care telemedicine

Intervention Type OTHER

Patient Monitoring

Undergo remote monitoring

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy medical monitoring monitor

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No