N/A
N=128
Mobile Health Study and Enhanced Symptom Monitoring in COVID-19 Cancer Patients
Sars-CoV2 · Covid-19
Bottom Line
View on ClinicalTrials.gov: NCT04397614 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Proportion of Smartphone Based Surveys Completed — 0.46; 0.44 proportion of daily surveys completed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mHealth Assessments (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Smartphone Based Surveys Completed |
0.46; 0.44 | — |
| PRIMARY Number of Participants With Manifestations of Severe Disease |
25; 5 | — |
| PRIMARY Number of Participants With SARS-CoV-2 Related Hospital Admission |
5; 1 | — |
| PRIMARY Number of Participants With SARS-CoV-2 Related ICU Admission |
0; 1 | — |
| PRIMARY Number of Participants With SARS-CoV-2 That Needed Invasive Mechanical Ventilation |
0; 0 | — |
| PRIMARY Mortality Number for Participants Who Reported SARS-CoV-2 Positive and Got Enhanced Monitoring |
6; 1 | — |
| SECONDARY Percent of Participants Satisfied With Monitoring and Use of mHealth Application |
49; 3; 47; 4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04397614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.