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

NCT04397614 | Completed Results

• 2 other identifiers: COVID-19 Mobile Health3P30CA225520-03S3
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Sars-CoV2; Covid-19

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Percent of Participants Satisfied With Monitoring and Use of mHealth Application

  24 weeks

Study Arms (2)

No Elevated Risk for COVID-19 Detected

EXPERIMENTAL

Continue daily mHealth assessments

Other: mHealth Assessments

Elevated Risk for COVID-19 Detected

EXPERIMENTAL

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

Other: mHealth Assessments

Interventions

mHealth Assessments OTHER

Daily symptom tracker

Elevated Risk for COVID-19 Detected; No Elevated Risk for COVID-19 Detected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Oklahoma: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

None to report

Results Point of Contact

• Title: Krista Kezbers
• Organization: University of Oklahoma Health Sciences Center

krista-kezbers@ouhsc.edu

405-271-8001

Study Officials

• Bethany Hannafon, PhD

  The University of Oklahoma Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Michael Businelle, PhD

  The University of Oklahoma Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 21, 2020
• Study Start: July 22, 2020
• Primary Completion: November 12, 2021
• Study Completion: November 12, 2021
• Last Updated: April 24, 2023
• Results First Posted: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)