Mobile Health Study and Enhanced Symptom Monitoring in COVID-19 Cancer Patients

University of Oklahoma (OU)

Status: Completed

Conditions: Sars-CoV2; Covid-19

Treatments: Other: mHealth Assessments

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04397614

COVID-19 Mobile Health

3P30CA225520-03S3 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The established Insight(TM) mHealth Platform, a component of the Stephenson Cancer Center (SCC) mHealth Shared Resource will be used to create the "Symptom Tracker" app. The Symptom Tracker (Insight(TM)) app will enable real-time monitoring of cancer patient symptoms that are consistent with early signs of SARS-CoV-2 infection in this high-risk population by automatically (and securely) transferring this information to health care providers. The primary aim of this study is to determine the feasibility, ease of use, and perceived utility of this app to monitor symptoms and health risk behaviors among cancer patients currently receiving chemotherapy.

Full description

A total of 500 treatment-seeking males and females will be asked to complete daily monitoring of symptoms via smartphone app. Those who screen positive for COVID-19 will be triaged to emergency or non-emergency medical treatment and will receive a study supplied device to measure their oxygen level and heart rate and be instructed in the device's use. They will be prompted to enter vital signs data (such as oxygen level) daily (and as indicated by changes in status) and questions from the app will change to assess the severity of COVID-19 related symptoms and inform changes in level of care, to emergency or non-emergency medical management as indicated by self-reporting. The proposed study will assess the impact of heightened symptom and vital sign monitoring on the early identification of severe manifestations of COVID-19 in this high-risk population (Aim 2). It is hypothesized that this will significantly improve COVID-19 related morbidity and mortality compared to the national and international rates currently reported in the literature.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Demonstrate > 6th grade English literacy level (i.e., phone based EMAs require >6th grade literacy)
2. Present for care at the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center
3. Are currently receiving systemic chemotherapy by intravenous infusion or by orally delivered medication
4. Are greater than or equal to 18 years of age
5. Are willing and able to complete surveys on their personal smartphone or a study provided smartphone
6. Are willing and able to provide informed consent

Exclusion criteria

• None

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

No Elevated Risk for COVID-19 Detected

Experimental group

Description:

Continue daily mHealth assessments

Treatment:

Other: mHealth Assessments

Elevated Risk for COVID-19 Detected

Experimental group

Description:

Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur.

Treatment:

Other: mHealth Assessments