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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05038254
Other study ID # 2020-0702
Secondary ID NCI-2021-0746420
Status Recruiting
Phase N/A
First received
Last updated
Start date May 12, 2021
Est. completion date January 31, 2026

Study information

Verified date January 2024
Source M.D. Anderson Cancer Center
Contact Ryan W Huey, MD
Phone 713-792-2828
Email remotemonitoringprogram@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 750
Est. completion date January 31, 2026
Est. primary completion date January 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular
  • Carcinoma, Squamous Cell
  • 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
  • Colonic Neoplasms
  • Digestive System Neoplasms
  • Esophageal Neoplasms
  • Esophageal Squamous Cell Carcinoma
  • Gastrointestinal Neoplasms
  • Gastrointestinal Stromal Tumors
  • Intestinal Neoplasms
  • Metastatic Colon Carcinoma
  • Metastatic Esophageal Carcinoma
  • Metastatic Gastric Carcinoma
  • Metastatic Liver Carcinoma
  • Metastatic Malignant Digestive System Neoplasm
  • Metastatic Pancreatic Carcinoma
  • Metastatic Rectal Carcinoma
  • Neoplasms
  • 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 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 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 Neoplasms
  • Thoracic Neoplasms

Intervention

Other:
Best Practice
Receive standard of care telemedicine
Procedure:
Patient Monitoring
Undergo remote monitoring
Other:
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of acute care visits Defined as the proportion of unique oncology patients with emergency room visits or hospital admission over a 3-month period. Up to 3 months
Secondary Change in health-related quality of life (HRQOL) HRQOL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 version 2.1. Baseline to 6 months
Secondary Change in patient engagement 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 Baseline to 6 months
Secondary Change in symptom management Daily symptoms will be measured using the Common Terminology Criteria for Adverse Events version 5. Baseline to 6 months
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