Clinical trial NCT04397614: Mobile Health Study and Enhanced Symptom Monitoring in COVID-19 Cancer Patients
Official title: Mobile Health Study and Enhanced Symptom Monitoring to Prevent Severe Illness From COVID-19 in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sars-CoV2
Covid-19
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-05-21
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Smartphone Based Surveys Completed
timeFrame: up to 24 weeks
measure: Number of Participants With Manifestations of Severe Disease
timeFrame: up to 24 weeks
measure: Number of Participants With SARS-CoV-2 Related Hospital Admission
timeFrame: up to 24 weeks
measure: Number of Participants With SARS-CoV-2 Related ICU Admission
timeFrame: up to 24 weeks
measure: Number of Participants With SARS-CoV-2 That Needed Invasive Mechanical Ventilation
timeFrame: up to 24 weeks
measure: Mortality Number for Participants Who Reported SARS-CoV-2 Positive and Got Enhanced Monitoring
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Percent of Participants Satisfied With Monitoring and Use of mHealth Application
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
Study officials:
affiliation: The University of Oklahoma Health Sciences Center
name: Bethany Hannafon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Oklahoma Health Sciences Center
name: Michael Businelle, PhD
role: PRINCIPAL_INVESTIGATOR
References: