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Enrolling by Invitation

NCT Number: NCT04357574

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke Cancer Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telehealth

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Number of missed telehealth clinical evaluation visits during COVID-19

    Time frame: 12 months

  2. Number of unplanned emergency department visits or hospital admissions during COVID-19

    Time frame: 12 months

  3. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of California, San Diego

Registry information

Official study title

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

Acronym: CORONA-SHIELD

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2020
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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