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

Not Applicable

Recruiting

• Conditions: Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IVA Gastric Cancer AJCC v8; Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage IVB Gastric Cancer AJCC v8; Metastatic Rectal Carcinoma; Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8; Metastatic Gastric Carcinoma; Metastatic Malignant Digestive System Neoplasm; Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8; Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8
• Interventions: Other: Best Practice; Other: Questionnaire Administration; Procedure: Patient Monitoring

• Registration Number: NCT05038254
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Detailed 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.

Study Timeline

• Study Start: 2021-05-12
• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (standard of care)	Questionnaire Administration	Patients receive standard of care consisting of oncology care provided via telemedicine.
Arm II (standard of care, remote monitoring)	Questionnaire Administration	Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.
Arm I (standard of care)	Best Practice	Patients receive standard of care consisting of oncology care provided via telemedicine.
Arm II (standard of care, remote monitoring)	Patient Monitoring	Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.
Arm II (standard of care, remote monitoring)	Best Practice	Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.
Arm III (standard of care, remote monitoring, biometrics)	Best Practice	Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring.
Arm III (standard of care, remote monitoring, biometrics)	Questionnaire Administration	Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring.
Arm III (standard of care, remote monitoring, biometrics)	Patient Monitoring	Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States