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OpenTrials
Completed

NCT Number: NCT04277650

System for High-Intensity Evaluation During Radiotherapy

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.

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Key information

Conditions

Radiation Therapy Complication Chemotherapeutic Toxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Cancer Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Machine learning algorithm

Other

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

Primary outcomes

  1. Number of unplanned emergency department visits or hospital admissions

    Time frame: 6 months

Secondary outcomes

  1. Number of unplanned emergency department visits or hospital admissions up to 15 days post radiation treatment

    Time frame: up to 15 days post radiation treatment

  2. Number of missed clinical evaluation visits

    Time frame: 6 months

  3. 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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study 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

Acronym: SHIELD-RT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2020
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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