SHIELD-RT: System for High-Intensity Evaluation During Radiotherapy

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT04277650

Collaborator

(none)

311

Enrollment

Location

Arms

9.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiation Therapy Complication Chemotherapeutic Toxicity	Other: Machine learning algorithm	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

311 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

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.

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Sep 7, 2018

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Once weekly clinical evaluation Outpatient participants evaluated as high risk by the machine learning algorithm and provided once weekly clinical evaluations	Other: Machine learning algorithm machine learning directed identification of radiotherapy or chemoradiotherapy patients at high-risk for emergency department acute care and/or hospitalization
Experimental: Twice weekly clinical evaluation Outpatient participants evaluated as high risk by the machine learning algorithm and provided twice weekly clinical evaluations	Other: Machine learning algorithm machine learning directed identification of radiotherapy or chemoradiotherapy patients at high-risk for emergency department acute care and/or hospitalization

Arm

Intervention/Treatment

Active Comparator: Once weekly clinical evaluation

Outpatient participants evaluated as high risk by the machine learning algorithm and provided once weekly clinical evaluations

Other: Machine learning algorithm

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

Experimental: Twice weekly clinical evaluation

Outpatient participants evaluated as high risk by the machine learning algorithm and provided twice weekly clinical evaluations

Other: Machine learning algorithm

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

Outcome Measures

Primary Outcome Measures

Number of unplanned emergency department visits or hospital admissions [6 months]

Secondary Outcome Measures

Number of unplanned emergency department visits or hospital admissions up to 15 days post radiation treatment [up to 15 days post radiation treatment]
Number of missed clinical evaluation visits [6 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 [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke Cancer Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator: Manisha Palta, MD, Duke Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT04277650

Other Study ID Numbers:

Pro00100647

First Posted:

Feb 20, 2020

Last Update Posted:

May 19, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 19, 2021