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

• Sponsor: University of Oklahoma (Other)
• Overall Status: Completed
• CT.gov ID: NCT04397614
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.7
• Patients Per Site Per Month: 8.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sars-CoV2; Covid-19	Other: mHealth Assessments	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Mobile Health Study and Enhanced Symptom Monitoring to Prevent Severe Illness From COVID-19 in Cancer Patients
• Actual Study Start Date: Jul 22, 2020
• Actual Primary Completion Date: Nov 12, 2021
• Actual Study Completion Date: Nov 12, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of completion of smartphone based surveys [up to 24 weeks]

2. Time to resolution of symptoms [up to 24 weeks]

3. Hospitalization Status [up to 24 weeks]

   Yes/No

4. Manifestations of severe disease [up to 24 weeks]

   Yes/No

5. SARS-CoV-2 Related Hospital Admission [up to 24 weeks]

   Yes/No

6. SARS-CoV-2 related ICU Admission [up to 24 weeks]

   Yes/No

7. SARS-CoV-2 need for invasive mechanical ventilation [up to 24 weeks]

   Yes/No

8. SARS-CoV-2 related mortality [up to 24 weeks]

   Yes/No

Secondary Outcome Measures

1. Percent satisfied with monitoring and use of mHealth application [24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stephenson Cancer Center	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

• University of Oklahoma

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT04397614
• Other Study ID Numbers: COVID-19 Mobile Health
• First Posted: May 21, 2020
• Last Update Posted: Jan 27, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Jan 27, 2022