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Assessing the System for High-Intensity Evaluation During Radiotherapy During Changes in Response to COVID-19

Assessing the Provider Implementation and Experience of TeleHealth During COVID-19 and Impact on Acute Encounters

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04357574
Acronym
CORONA-SHIELD
Enrollment
1000
Registered
2020-04-22
Start date
2020-04-14
Completion date
2027-04-01
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, COVID-19

Brief 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 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.

Interventions

OTHERTelehealth

patients have virtual visits with Radiation Oncology providers in lieu of in person clinic visits as a necessary response to COVID-19

Sponsors

Duke University
Lead SponsorOTHER
University of California, San Diego
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• started outpatient radiation therapy with or without concurrent systemic therapy at Duke Cancer Center during the COVID-19 outbreak

Exclusion criteria

* undergoing total body radiation therapy for hematopoetic stem cell transplantation * undergoing therapy as inpatient * completed radiation therapy prior to algorithm execution

Design outcomes

Primary

MeasureTime frameDescription
Radiation Oncology providers perception of of telehealth for on treatment patients in lieu of in person on treatment visits during COVID-1912 monthssurvey assessment scored as strongly agree (positive perception) through strongly disagree (negative perception)

Secondary

MeasureTime frame
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-1912 months
Number of missed telehealth clinical evaluation visits during COVID-1912 months
Number of unplanned emergency department visits or hospital admissions during COVID-1912 months

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORManisha Palta, MD

Duke Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026