Clinical trial NCT05038254: Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of acute care visits
timeFrame: Up to 3 months
Secondary outcomes:
measure: Change in health-related quality of life (HRQOL)
timeFrame: Baseline to 6 months
measure: Change in patient engagement
timeFrame: Baseline to 6 months
measure: Change in symptom management
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ryan W Huey, MD
role: PRINCIPAL_INVESTIGATOR
References: