Sars-CoV2NCT04397614
Mobile Health Study and Enhanced Symptom Monitoring in COVID-19 Cancer Patients
A study testing mHealth Assessments in people with Sars-CoV2 and Covid-19, run by University of Oklahoma at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- mHealth Assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2020to 12 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Mobile Health Study and Enhanced Symptom Monitoring to Prevent Severe Illness From COVID-19 in 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.
Read the 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.
- Being tested
- mHealth Assessments
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth AssessmentsOther
Daily symptom tracker
| Study group | Role | What they receive |
|---|---|---|
| No Elevated Risk for COVID-19 Detected | Experimental | Continue daily mHealth assessments Receives: 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. Receives: Other: mHealth Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 24 weeks
Secondary outcomes (1)
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start22 Jul 2020
- Primary completion12 Nov 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bethany Hannafon, PhD, Principal investigator, The University of Oklahoma Health Sciences CenterMichael Businelle, PhD, Principal investigator, The University of Oklahoma Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397614
- Sponsor's protocol ID
- COVID-19 Mobile Health
- Other IDs
- 3P30CA225520-03S3
- Status last verified
- Apr 2023
- First submitted
- 20 May 2020
- Last updated
- 24 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shao R, Neil JM, Chen M, Hannafon B, Nipp R, Montgomery A, Frank-Pearce SG, Moxley K, Richardson DL, Elliott J, Benson L, Gossett AG, Businelle MS. A mobile health app for real-time symptom monitoring in patients with cancer during COVID-19: feasibility, acceptability, and utility. BMC Cancer. 2026 Feb 20;26(1):408. doi: 10.1186/s12885-026-15772-2.
PubMed 41715027
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Study and Enhanced Symptom Monitoring to Prevent Severe Illness From COVID-19 in Cancer Patients
- ClinicalTrials.gov ID
- NCT04397614
- Acronym / sponsor ID
- COVID-19 Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Posted 24 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Elevated Risk for COVID-19 Detected | Experimental | Other: mHealth AssessmentsContinue daily mHealth assessments |
| Elevated Risk for COVID-19 Detected | Experimental | Other: mHealth AssessmentsDaily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth AssessmentsDaily symptom tracker | Other | Elevated Risk for COVID-19 Detected, No Elevated Risk for COVID-19 Detected |
Primary outcome
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)
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
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
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
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
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
1 secondary outcome
Percent of Participants Satisfied With Monitoring and Use of mHealth Application
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41715027Shao R, Neil JM, Chen M, Hannafon B, Nipp R, Montgomery A, Frank-Pearce SG, Moxley K, Richardson DL, Elliott J, Benson L, Gossett AG, Businelle MS. A mobile health app for real-time symptom monitoring in patients with cancer during COVID-19: feasibility, acceptability, and utility. BMC Cancer. 2026 Feb 20;26(1):408. doi: 10.1186/s12885-026-15772-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bethany Hannafon, PhD principal investigator
The University of Oklahoma Health Sciences Center
Michael Businelle, PhD principal investigator
The University of Oklahoma Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Assessments in people with Sars-CoV2 and Covid-19, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Smartphone Based Surveys Completed (time frame: up to 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04397614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.