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

Status: active

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.

Inclusion Criteria

Adults (>= 18 years)
English-and Spanish- fluent with thoracic and/or gastrointestinal cancers who are scheduled to initiate or continue outpatient chemotherapy at either M D Anderson Cancer Center (MDACC) (Texas Medical Center location) or MDACC oncology clinic at Lyndon B Johnson (LBJ) hospital
Their adult (>= 18 years) patient-identified or self-identified primary caregivers (MDACC only)
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
Patients on combination chemotherapy and immunotherapy or combination chemotherapy and biologic will also be eligible for inclusion
DIGITAL PHENOTYPING OBSERVATIONAL STUDY CRITERIA: > 18 years old
DIGITAL PHENOTYPING OBSERVATIONAL STUDY CRITERIA: English speaking
DIGITAL PHENOTYPING OBSERVATIONAL STUDY CRITERIA: Able to provide informed consent
DIGITAL PHENOTYPING OBSERVATIONAL STUDY CRITERIA: Have a diagnosis of gastrointestinal and thoracic cancer and enrolled in the ongoing effectiveness trial at both sites
DIGITAL PHENOTYPING OBSERVATIONAL STUDY CRITERIA: Eastern Cooperative Oncology Group (ECOG) performance status <3
DIGITAL PHENOTYPING OBSERVATIONAL STUDY CRITERIA: Willingness to wear a Fitbit Charge HR (Fitbit Inc) device, a wrist-worn passive activity tracker, continuously for the 3-month study period (to collect continuous physical activity, heart rate, and sleep data)

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

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.

II. To evaluate the utility of digital phenotyping (i.e., passive sensing technologies for the detection of physiologic states) to predict health outcomes such as symptoms and health resource utilization in patients undergoing chemotherapy.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive standard of care consisting of oncology care provided via telemedicine. Patients may optionally undergo passive activity monitoring wearing Fitbit device.

ARM II: Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo self-reporting of treatment-related symptoms using a smartphone application. Patients may optionally undergo passive activity monitoring wearing Fitbit device.

ARM III: Patients receive standard of care consisting of oncology care provided via telemedicine. Patient also undergo comprehensive remote patient monitoring of treatment-related symptom burden and vital signs. Patients may optionally undergo passive activity monitoring wearing Fitbit device.

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

Inclusion Criteria

Exclusion Criteria

United States

Texas

Houston

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

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