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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-14

Study Completion Date

2026-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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COVID-19 Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Radiation Oncology Providers

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

Telehealth

Intervention Type OTHER

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

Interventions

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Telehealth

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No