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

Primary Purpose

Sars-CoV2, Covid-19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth Assessments
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sars-CoV2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stephenson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

No Elevated Risk for COVID-19 Detected

Elevated Risk for COVID-19 Detected

Arm Description

Continue daily mHealth assessments

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

Outcomes

Primary Outcome Measures

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)
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
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
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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
May 20, 2020
Last Updated
April 21, 2023
Sponsor
University of Oklahoma
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04397614
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
November 12, 2021 (Actual)
Study Completion Date
November 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars-CoV2, Covid-19

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Elevated Risk for COVID-19 Detected
Arm Type
Experimental
Arm Description
Continue daily mHealth assessments
Arm Title
Elevated Risk for COVID-19 Detected
Arm Type
Experimental
Arm Description
Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur.
Intervention Type
Other
Intervention Name(s)
mHealth Assessments
Intervention Description
Daily symptom tracker
Primary Outcome Measure Information:
Title
Proportion of Smartphone Based Surveys Completed
Description
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)
Time Frame
up to 24 weeks
Title
Number of Participants With Manifestations of Severe Disease
Description
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
Time Frame
up to 24 weeks
Title
Number of Participants With SARS-CoV-2 Related Hospital Admission
Description
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
Time Frame
up to 24 weeks
Title
Number of Participants With SARS-CoV-2 Related ICU Admission
Description
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
Time Frame
up to 24 weeks
Title
Number of Participants With SARS-CoV-2 That Needed Invasive Mechanical Ventilation
Description
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
Time Frame
up to 24 weeks
Title
Mortality Number for Participants Who Reported SARS-CoV-2 Positive and Got Enhanced Monitoring
Description
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
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Percent of Participants Satisfied With Monitoring and Use of mHealth Application
Description
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
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bethany Hannafon, PhD
Organizational Affiliation
The University of Oklahoma Health Sciences Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Businelle, PhD
Organizational Affiliation
The University of Oklahoma Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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