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

Not Applicable

Completed

• Conditions: Sars-CoV2; Covid-19
• Interventions: Other: mHealth Assessments

• Registration Number: NCT04397614
• Lead Sponsor: University of Oklahoma

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.

Study Timeline

• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-21
• Study Start: 2020-07-22
• Primary Completion: 2021-11-12
• Study Completion: 2021-11-12
• Results First Submitted: 2023-03-02
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-21
• Last Update Submitted: 2023-04-21
• Results First Posted: 2023-04-24
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elevated Risk for COVID-19 Detected	mHealth Assessments	Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur.
No Elevated Risk for COVID-19 Detected	mHealth Assessments	Continue daily mHealth assessments

Primary Outcome Measures

Name	Time	Method
Number of Participants With Manifestations of Severe Disease	up to 24 weeks	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
Number of Participants With SARS-CoV-2 Related ICU Admission	up to 24 weeks	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
Number of Participants With SARS-CoV-2 That Needed Invasive Mechanical Ventilation	up to 24 weeks	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
Proportion of Smartphone Based Surveys Completed	up to 24 weeks	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)
Number of Participants With SARS-CoV-2 Related Hospital Admission	up to 24 weeks	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
Mortality Number for Participants Who Reported SARS-CoV-2 Positive and Got Enhanced Monitoring	up to 24 weeks	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

Secondary Outcome Measures

Name	Time	Method
Percent of Participants Satisfied With Monitoring and Use of mHealth Application	24 weeks	1. 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; 2. 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

Trial Locations

Locations (1)

Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States