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NCT Number: NCT04397614

Mobile Health Study and Enhanced Symptom Monitoring in COVID-19 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.

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Key information

Conditions

Sars-CoV2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

mHealth Assessments

Other

Daily symptom tracker

Primary outcomes

  1. Proportion of Smartphone Based Surveys Completed

    Time frame: 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)

  2. Number of Participants With Manifestations of Severe Disease

    Time frame: 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

  3. Number of Participants With SARS-CoV-2 Related Hospital Admission

    Time frame: 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

  4. Number of Participants With SARS-CoV-2 Related ICU Admission

    Time frame: 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

  5. Number of Participants With SARS-CoV-2 That Needed Invasive Mechanical Ventilation

    Time frame: 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

  6. Mortality Number for Participants Who Reported SARS-CoV-2 Positive and Got Enhanced Monitoring

    Time frame: 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 outcomes

  1. Percent of Participants Satisfied With Monitoring and Use of mHealth Application

    Time frame: 24 weeks

    • 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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 21, 2020
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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