System for High-Intensity Evaluation During Radiotherapy

Chemotherapeutic Toxicity Clinical Trial

— SHIELD-RT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277650
• Other study ID #: Pro00100647
• Status: Completed
• Phase: N/A
• Start date: September 7, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapeutic Toxicity
• Radiation Therapy Complication

Intervention

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

Locations

Country	Name	City	State
United States	Duke Cancer Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hong JC, Eclov NCW, Dalal NH, Thomas SM, Stephens SJ, Malicki M, Shields S, Cobb A, Mowery YM, Niedzwiecki D, Tenenbaum JD, Palta M. System for High-Intensity Evaluation During Radiation Therapy (SHIELD-RT): A Prospective Randomized Study of Machine Learn — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of unplanned emergency department visits or hospital admissions		6 months
Secondary	Number of unplanned emergency department visits or hospital admissions up to 15 days post radiation treatment		up to 15 days post radiation treatment
Secondary	Number of missed clinical evaluation visits		6 months
Secondary	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		6 months