Esophageal Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Adults (>= 18 years)
English- fluent with metastatic thoracic and gastrointestinal (esophagus, stomach, liver, pancreas, small bowel, colon, and rectum) who are scheduled to initiate outpatient chemotherapy (cycle 1, dose 1) at M D Anderson Cancer Center (MDACC) (Texas Medical Center location)
Their adult (>= 18 years) patient-identified or self-identified primary caregivers
Patients may participate if they do not have a caregiver, or if their caregiver declines participation; however, caregivers may participate only if the patient consents

Exclusion Criteria:

Patients receiving investigational drug treatments or concurrently enrolled in a phase 1 clinical trial will be excluded due to the associated structured reporting and regulatory requirements
Patients with a requirement for inpatient infusion (i.e. CAR-T cell therapy), living in institutional settings (i.e. prison), with a history of dementia, physical disability or neurological deficits that prohibit ability to report symptom burden will also be excluded

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

600

Study ID:

NCT05038254

Recruitment Status:

Recruiting

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Ryan W Huey
Contact
713-792-2828
[email protected]
Ryan W Huey
Principal Investigator

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Study is for people with:

Esophageal Cancer

Estimated Enrollment:

600

Study ID:

NCT05038254

Recruitment Status:

Recruiting

Sponsor:


M.D. Anderson Cancer Center

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