Trial Outcomes & Findings for Mobile Health Study and Enhanced Symptom Monitoring in COVID-19 Cancer Patients (NCT NCT04397614)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

128 participants

Primary outcome timeframe

up to 24 weeks

Results posted on

2023-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	No Elevated Risk for COVID-19 Detected Continue daily mHealth assessments mHealth Assessments: Daily symptom tracker	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
Overall Study STARTED	121	7
Overall Study COMPLETED	57	4
Overall Study NOT COMPLETED	64	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Elevated Risk for COVID-19 Detected n=121 Participants Continue daily mHealth assessments mHealth Assessments: Daily symptom tracker	Elevated Risk for COVID-19 Detected n=7 Participants Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur. mHealth Assessments: Daily symptom tracker	Total n=128 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 12.56 • n=5 Participants	50.71 years STANDARD_DEVIATION 12.56 • n=7 Participants	57.60 years STANDARD_DEVIATION 13.01 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	5 Participants n=7 Participants	99 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	2 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	95 Participants n=5 Participants	4 Participants n=7 Participants	99 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	No Elevated Risk for COVID-19 Detected n=121 Participants Continue daily mHealth assessments mHealth Assessments: Daily symptom tracker	Elevated Risk for COVID-19 Detected n=7 Participants Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur. mHealth Assessments: Daily symptom tracker
Proportion of Smartphone Based Surveys Completed	0.46 proportion of daily surveys completed Standard Deviation 0.38	0.44 proportion of daily surveys completed Standard Deviation 0.25

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	No Elevated Risk for COVID-19 Detected n=121 Participants Continue daily mHealth assessments mHealth Assessments: Daily symptom tracker	Elevated Risk for COVID-19 Detected n=7 Participants Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur. mHealth Assessments: Daily symptom tracker
Number of Participants With Manifestations of Severe Disease	25 Participants	5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	No Elevated Risk for COVID-19 Detected n=121 Participants Continue daily mHealth assessments mHealth Assessments: Daily symptom tracker	Elevated Risk for COVID-19 Detected n=7 Participants Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur. mHealth Assessments: Daily symptom tracker
Number of Participants With SARS-CoV-2 Related Hospital Admission	5 Participants	1 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	No Elevated Risk for COVID-19 Detected n=121 Participants Continue daily mHealth assessments mHealth Assessments: Daily symptom tracker	Elevated Risk for COVID-19 Detected n=7 Participants Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur. mHealth Assessments: Daily symptom tracker
Number of Participants With SARS-CoV-2 Related ICU Admission	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	No Elevated Risk for COVID-19 Detected n=121 Participants Continue daily mHealth assessments mHealth Assessments: Daily symptom tracker	Elevated Risk for COVID-19 Detected n=7 Participants Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur. mHealth Assessments: Daily symptom tracker
Number of Participants With SARS-CoV-2 That Needed Invasive Mechanical Ventilation	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	No Elevated Risk for COVID-19 Detected n=121 Participants Continue daily mHealth assessments mHealth Assessments: Daily symptom tracker	Elevated Risk for COVID-19 Detected n=7 Participants Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur. mHealth Assessments: Daily symptom tracker
Mortality Number for Participants Who Reported SARS-CoV-2 Positive and Got Enhanced Monitoring	6 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Participants who completed the follow-up assessments

1. 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 2. 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

Outcome measures

Outcome measures
Measure	No Elevated Risk for COVID-19 Detected n=57 Participants Continue daily mHealth assessments mHealth Assessments: Daily symptom tracker	Elevated Risk for COVID-19 Detected n=4 Participants Daily mHealth assessments and telemedicine/nurse triage. If non-emergent intervention, enhanced symptom monitoring will occur. mHealth Assessments: Daily symptom tracker
Percent of Participants Satisfied With Monitoring and Use of mHealth Application satisfied with number of assessments	49 Participants	3 Participants
Percent of Participants Satisfied With Monitoring and Use of mHealth Application interested in using a similar smartphone app if needed	47 Participants	4 Participants

Adverse Events

No Elevated Risk for COVID-19 Detected

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Elevated Risk for COVID-19 Detected

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Krista Kezbers

University of Oklahoma Health Sciences Center

Phone: 405-271-8001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place