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
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm I (standard of care) | Active comparator | Other: Best Practice; Other: Questionnaire Administration | Patients receive standard of care consisting of oncology care provided via telemedicine. |
| Arm II (standard of care, remote monitoring) | Experimental | Other: Best Practice; Procedure: Patient Monitoring; Other: Questionnaire Administration | Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring. |
| Arm III (standard of care, remote monitoring, biometrics) | Experimental | Other: Best Practice; Procedure: Patient Monitoring; Other: Questionnaire Administration | Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring. |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| M D Anderson Cancer Center | Houston, Texas | United States |