Skip to content

System for High-Intensity Evaluation During Radiotherapy

System for High Intensity EvaLuation During Radiation Therapy (SHIELD-RT): A Prospective Randomized Study of Machine Learning-directed Clinical Evaluations During Outpatient Cancer Radiation and Chemoradiation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04277650
Acronym
SHIELD-RT
Enrollment
311
Registered
2020-02-20
Start date
2018-09-07
Completion date
2019-06-30
Last updated
2021-05-19

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

Conditions

Chemotherapeutic Toxicity, Radiation Therapy Complication

Brief summary

This quality improvement project will evaluate the implementation of a previously described intervention (twice per week on-treatment clinical evaluations) in a feasible fashion using a previously described machine learning algorithm identifying patients identified at high risk for an emergency visit or hospitalization during radiation therapy.

Interventions

machine learning directed identification of radiotherapy or chemoradiotherapy patients at high-risk for emergency department acute care and/or hospitalization

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

The ML directed twice-weekly evaluation arm was unblinded. Participants and providers were blinded to ML identification of high risk participants in the once weekly evaluation (standard of care) arm.

Intervention model description

Participants identified by the machine learning (ML) algorithm as high risk were randomized to either once weekly or twice weekly clinical evaluations

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

Exclusion criteria

* undergoing total body radiation therapy for hematopoetic stem cell transplantation * undergoing therapy as inpatient * treating physician who opted out of randomization * completed radiation therapy prior to algorithm execution

Design outcomes

Primary

MeasureTime frame
Number of unplanned emergency department visits or hospital admissions6 months

Secondary

MeasureTime frame
Number of unplanned emergency department visits or hospital admissions up to 15 days post radiation treatmentup to 15 days post radiation treatment
Number of missed clinical evaluation visits6 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 category6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026