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

Last updated: July 28, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Colon Cancer

Esophageal Cancer

Treatment

Questionnaire Administration

Best Practice

Patient Monitoring

Clinical Study ID

NCT05038254
2020-0702
2020-0702
NCI-2021-07464
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults (≥ 18 years)

  • English- and Spanish-fluent participants with thoracic and/or gastrointestinalcancers who are scheduled to initiate or continue outpatient chemotherapy at eitherMDACC (Texas Medical Center campus and any Houston-area location) or MDACC oncologyclinic 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 combinationchemotherapy and biologic will also be eligible for inclusion.

  • Participants may participate if they do not have a caregiver, or if their caregiverdeclines participation; however, caregivers of MDACC participants may participateonly if the participant consents.

Exclusion

Exclusion Criteria:

  • Participants who are receiving investigational new drug treatments or concurrentlyenrolled in a phase 1 clinical trial will be excluded due to the associatedstructured 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 ofdementia, physical disability or neurological deficits that prohibit ability toreport symptom burden will also be excluded.

Study Design

Total Participants: 750
Treatment Group(s): 3
Primary Treatment: Questionnaire Administration
Phase:
Study Start date:
May 12, 2021
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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