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

Mobile Health Study and Enhanced Symptom Monitoring to Prevent Severe Illness From COVID-19 in Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Covid-19; Sars-CoV2
• Intervention / Treatment: Other: mHealth Assessments

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No Elevated Risk for COVID-19 Detected; Continue daily mHealth assessments	Other: mHealth Assessments; Daily symptom tracker
Experimental: Elevated Risk for COVID-19 Detected; Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur.	Other: mHealth Assessments; Daily symptom tracker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Smartphone Based Surveys Completed	Proportion of completed smartphone-based daily surveys divided by the total number of surveys a participant is staged to receive (daily for 24 weeks = 168 surveys total)	up to 24 weeks
Number of Participants With Manifestations of Severe Disease	Yes/No; Yes = there were manifestations of severe disease; No = there were no manifestations of severe disease. Those who are marked as Yes are reported below in the Outcome measure data table	up to 24 weeks
Number of Participants With SARS-CoV-2 Related Hospital Admission	Yes/No; Yes = there were SARS-CoV-2 related hospital admissions; No = there were no SARS-CoV-2 related hospital admissions. Those who are marked as Yes are reported below in the Outcome measure data table	up to 24 weeks
Number of Participants With SARS-CoV-2 Related ICU Admission	Yes/No; Yes = there were SARS-CoV-2 related ICU admissions; No = there were no SARS-CoV-2 related ICU admissions. Those who are marked as Yes are reported below in the Outcome measure data table	up to 24 weeks
Number of Participants With SARS-CoV-2 That Needed Invasive Mechanical Ventilation	Yes/No; Yes = participant had SARS-CoV-2 and needed invasive mechanical ventilation; No = participant had SARS-CoV-2 and did not need invasive mechanical ventilation. Those who are marked as Yes are reported below in the Outcome measure data table	up to 24 weeks
Mortality Number for Participants Who Reported SARS-CoV-2 Positive and Got Enhanced Monitoring	Yes/No; Yes = participant mortality reported; No = participant mortality not reported. Those who are marked as Yes are reported below in the Outcome measure data table	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Participants Satisfied With Monitoring and Use of mHealth Application	if the participants were satisfied with the number of assessments prompted by the smartphone application - yes/no - those who reported yes are in the outcome measure data table below; if the participants would be interested in using a similar smartphone app in the future if needed - yes/no - those who reported yes are in the outcome measure data table below	24 weeks

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Bethany Hannafon, PhD, The University of Oklahoma Health Sciences Center; Principal Investigator: Michael Businelle, PhD, The University of Oklahoma Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2020
• Primary Completion (Actual): November 12, 2021
• Study Completion (Actual): November 12, 2021

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COVID-19 Mobile Health; 3P30CA225520-03S3 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No