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Active, Not Recruiting

NCT Number: NCT05038254

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 Adenocarcinoma Carcinoma Carcinoma, Hepatocellular 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 Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms 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 Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms 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 Rectal Diseases Rectal Neoplasms 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 Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Best Practice

Other

Receive standard of care telemedicine

Other names: standard of care, standard therapy

Patient Monitoring

Procedure

Undergo remote monitoring

Other names: medical monitoring, monitor

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Rate of acute care visits

    Time frame: 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 outcomes

  1. Change in health-related quality of life (HRQOL)

    Time frame: Baseline to 6 months

    HRQOL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 version 2.1.

  2. Change in patient engagement

    Time frame: 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

  3. Change in symptom management

    Time frame: Baseline to 6 months

    Daily symptoms will be measured using the Common Terminology Criteria for Adverse Events version 5.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Sep 9, 2021
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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