COVID-19CORONA-SHIELDNCT04357574
Assessing the System for High-Intensity Evaluation During Radiotherapy During Changes in Response to COVID-19
An observational study of COVID-19 and Cancer, run by Duke University at 1 site in United States.
Trial summary
The primary objective of this research study is to assess Radiation Oncology healthcare providers (i.e. faculty, residents and advanced practice providers (APPs) implementation and perception of telehealth for on treatment patients in lieu of in person on treatment visits during standard of care radiotherapy during… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Telehealth
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2020to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients undergoing radiation therapy in the Department of Radiation Oncology at Duke Cancer Center during the COVID-19 outbreak
Who may be able to join
- started outpatient radiation therapy with or without concurrent systemic therapy at Duke Cancer Center during the COVID-19 outbreak
Who cannot join
- undergoing total body radiation therapy for hematopoetic stem cell transplantation
- undergoing therapy as inpatient
- completed radiation therapy prior to algorithm execution
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing the Provider Implementation and Experience of TeleHealth During COVID-19 and Impact on Acute Encounters
The primary objective of this research study is to assess Radiation Oncology healthcare providers (i.e. faculty, residents and advanced practice providers (APPs) implementation and perception of telehealth for on treatment patients in lieu of in person on treatment visits during standard of care radiotherapy during COVID-19.
Read the detailed description
A secondary aim will be to evaluate the rates of acute care during COVID-19 with telehealth in comparison to the rates during our prior Quality Improvement (QI) project (NCT04277650), considering the risk prediction based on our previously developed ML algorithm. Patient risk during this period will be assessed by the ML algorithm and actual rates of Emergency Department visits and hospitalizations (acute encounters) will be compared to the results of our prior QI project. These data will be used to discern how actual rates of acute care compare to providers' expectations both with and without telehealth implementation. Reasons for acute encounters and associated healthcare costs compared to patients undergoing standard of care assessments in NCT04277650 will be assessed to determine the percentage that are COVID-19 related. Basic demographic, disease, location of acute care, form of clinical assessments (video, in-person, telephone, etc.), and treatment information regarding the patients will also be captured following the completion of the research project for assessment.
These endpoints will establish how our current COVID-19-based precautions impact treatment-related outcomes in patient care.
- Being tested
- Telehealth
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelehealthOther
patients have virtual visits with Radiation Oncology providers in lieu of in person clinic visits as a necessary response to COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Radiation Oncology Providers | Faculty physicians, residents and advanced practice providers in the Radiation Oncology Department in Duke University Health System (DUHS) Receives: Other: Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Oncology providers perception of of telehealth for on treatment patients in lieu of in person on treatment visits during COVID-19
survey assessment scored as strongly agree (positive perception) through strongly disagree (negative perception)
Measured: 12 months
Secondary outcomes (3)
Number of missed telehealth clinical evaluation visits during COVID-19
Measured: 12 months
Number of unplanned emergency department visits or hospital admissions during COVID-19
Measured: 12 months
Number of acute care visits with listed reason as anemia, nutrition (including dehydration), diarrhea, emesis, infectious (including fever, pneumonia, and sepsis), nausea, neutropenia, pain category during COVID-19
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start14 Apr 2020
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Manisha Palta, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357574
- Sponsor's protocol ID
- Pro00105266
- Acronym
- CORONA-SHIELD
- Status last verified
- Feb 2026
- First submitted
- 20 Apr 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Provider Implementation and Experience of TeleHealth During COVID-19 and Impact on Acute Encounters
- ClinicalTrials.gov ID
- NCT04357574
- Acronym / sponsor ID
- CORONA-SHIELD / Pro00105266
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this research study is to assess Radiation Oncology healthcare providers (i.e. faculty, residents and advanced practice providers (APPs) implementation and perception of telehealth for on treatment patients in lieu of in person on treatment visits during standard of care radiotherapy during COVID-19.
Detailed description
A secondary aim will be to evaluate the rates of acute care during COVID-19 with telehealth in comparison to the rates during our prior Quality Improvement (QI) project (NCT04277650), considering the risk prediction based on our previously developed ML algorithm. Patient risk during this period will be assessed by the ML algorithm and actual rates of Emergency Department visits and hospitalizations (acute encounters) will be compared to the results of our prior QI project. These data will be used to discern how actual rates of acute care compare to providers' expectations both with and without telehealth implementation. Reasons for acute encounters and associated healthcare costs compared to patients undergoing standard of care assessments in NCT04277650 will be assessed to determine the percentage that are COVID-19 related. Basic demographic, disease, location of acute care, form of clinical assessments (video, in-person, telephone, etc.), and treatment information regarding the patients will also be captured following the completion of the research project for assessment.
These endpoints will establish how our current COVID-19-based precautions impact treatment-related outcomes in patient care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Oncology Providers | – | Other: TelehealthFaculty physicians, residents and advanced practice providers in the Radiation Oncology Department in Duke University Health System (DUHS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing radiation therapy in the Department of Radiation Oncology at Duke Cancer Center during the COVID-19 outbreak
Key inclusion criteria (1 listed)
- started outpatient radiation therapy with or without concurrent systemic therapy at Duke Cancer Center during the COVID-19 outbreak
Key exclusion criteria (3 listed)
- undergoing total body radiation therapy for hematopoetic stem cell transplantation
- undergoing therapy as inpatient
- completed radiation therapy prior to algorithm execution
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 |
|---|---|---|
| Telehealthpatients have virtual visits with Radiation Oncology providers in lieu of in person clinic visits as a necessary response to COVID-19 | Other | Radiation Oncology Providers |
Primary outcome
Radiation Oncology providers perception of of telehealth for on treatment patients in lieu of in person on treatment visits during COVID-19
Time frame: 12 months
survey assessment scored as strongly agree (positive perception) through strongly disagree (negative perception)
3 secondary outcomes
Number of missed telehealth clinical evaluation visits during COVID-19
Time frame: 12 months
Number of unplanned emergency department visits or hospital admissions during COVID-19
Time frame: 12 months
Number of acute care visits with listed reason as anemia, nutrition (including dehydration), diarrhea, emesis, infectious (including fever, pneumonia, and sepsis), nausea, neutropenia, pain category during COVID-19
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- 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.
Manisha Palta, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Cancer, run by Duke University 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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 6 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Radiation Oncology providers perception of of telehealth for on treatment patients in lieu of in person on treatment visits during COVID-19 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.