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| ID | Type | Description | Link |
|---|---|---|---|
| 3P30CA225520-03S3 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Elevated Risk for COVID-19 Detected | Experimental | Continue daily 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth Assessments | Other | Daily symptom tracker |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Satisfied With Monitoring and Use of mHealth Application |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bethany Hannafon, PhD | The University of Oklahoma Health Sciences Center | Principal Investigator |
| Michael Businelle, PhD | The University of Oklahoma Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41715027 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Elevated Risk for COVID-19 Detected | Continue daily mHealth assessments mHealth Assessments: Daily symptom tracker |
| FG001 | Elevated Risk for COVID-19 Detected | Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur. mHealth Assessments: Daily symptom tracker |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Elevated Risk for COVID-19 Detected | Continue daily mHealth assessments mHealth Assessments: Daily symptom tracker |
| BG001 | Elevated Risk for COVID-19 Detected | Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur. mHealth Assessments: Daily symptom tracker |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | proportion of daily surveys completed | up to 24 weeks |
|
Adverse event data were collected during the duration of the study for each participant, up to 24 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Elevated Risk for COVID-19 Detected | Continue daily mHealth assessments mHealth Assessments: Daily symptom tracker |
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None to report
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Krista Kezbers | University of Oklahoma Health Sciences Center | 405-271-8001 | 45042 | krista-kezbers@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2022 | Feb 22, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 24, 2021 | Feb 24, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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 |
| 24 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | up to 24 weeks |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | up to 24 weeks |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | up to 24 weeks |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | up to 24 weeks |
|
|
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| Primary | 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 | Posted | Count of Participants | Participants | up to 24 weeks |
|
|
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| Secondary | Percent of Participants Satisfied With Monitoring and Use of mHealth Application |
| Participants who completed the follow-up assessments | Posted | Count of Participants | Participants | 24 weeks |
|
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| 6 |
| 121 |
| 0 |
| 121 |
| 0 |
| 121 |
| EG001 | Elevated Risk for COVID-19 Detected | Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur. mHealth Assessments: Daily symptom tracker | 1 | 7 | 0 | 7 | 0 | 7 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |