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

NCT04357574 | Enrolling By Invitation

• 1 other identifier: Pro00105266
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Cancer

Outcome Measures

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

  survey assessment scored as strongly agree (positive perception) through strongly disagree (negative perception)

  12 months

Secondary Outcomes (3)

• Number of missed telehealth clinical evaluation visits during COVID-19

  12 months

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

  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

  12 months

Study Arms (1)

Radiation Oncology Providers

Faculty physicians, residents and advanced practice providers in the Radiation Oncology Department in Duke University Health System (DUHS)

Other: Telehealth

Interventions

Telehealth OTHER

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

Radiation Oncology Providers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing radiation therapy in the Department of Radiation Oncology at Duke Cancer Center during the COVID-19 outbreak

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• University of California, San Diego: collaborator

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

COVID-19; Neoplasms

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Manisha Palta, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: April 14, 2020
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)