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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05038254

Collaborator

(none)

600

Enrollment

Location

Arms

19.6

Anticipated Duration (Months)

30.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

Detailed Description

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVE:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

There Is No Place Like Home- A Pragmatic Effectiveness Trial of Technology-Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events

Actual Study Start Date :

May 12, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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 Names: standard of care standard therapy 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 Other Names: standard of care standard therapy Procedure: Patient Monitoring Undergo remote monitoring Other Names: medical monitoring monitor Other: Questionnaire Administration Ancillary studies

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 Names:

standard of care

standard therapy

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

Other Names:

standard of care

standard therapy

Procedure: Patient Monitoring

Undergo remote monitoring

Other Names:

medical monitoring

monitor

Other: Questionnaire Administration

Ancillary studies

Outcome Measures

Primary Outcome Measures

Rate of acute care visits [Up to 3 months]
Defined as the proportion of unique oncology patients with emergency room visits or hospital admission over a 3-month period.

Secondary Outcome Measures

Change in health-related quality of life (HRQOL) [Baseline to 6 months]
HRQOL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 version 2.1.
Change in patient engagement [Baseline to 6 months]
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
Change in symptom management [Baseline to 6 months]
Daily symptoms will be measured using the Common Terminology Criteria for Adverse Events version 5.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults (>= 18 years)
English- fluent with metastatic thoracic and gastrointestinal (esophagus, stomach, liver, pancreas, small bowel, colon, and rectum) who are scheduled to initiate outpatient chemotherapy (cycle 1, dose 1) at M D Anderson Cancer Center (MDACC) (Texas Medical Center location)
Their adult (>= 18 years) patient-identified or self-identified primary caregivers
Patients may participate if they do not have a caregiver, or if their caregiver declines participation; however, caregivers may participate only if the patient consents

Exclusion Criteria:

Patients receiving investigational drug treatments or concurrently enrolled in a phase 1 clinical trial will be excluded due to the associated structured reporting and regulatory requirements
Patients with a requirement for inpatient infusion (i.e. CAR-T cell therapy), living in institutional settings (i.e. prison), with a history of dementia, physical disability or neurological deficits that prohibit ability to report symptom burden will also be excluded