Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE)

Completed · Phase 2

Conditions studied: Pediatric Cancer

In brief

PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect) is an interactive incentive-based movie system that integrates with a video surveillance gating module (VisionRT) as an alternative sedation solution for pediatric patients undergoing radiation treatment (RT). This single-arm, open label, single-center phase II clinical trial is to implement PROMISE for all children ages 3-11 who are planned to undergo RT at the institution. The primary goal is to decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE, with secondary goals being to assess the impact that PROMISE has on patient/family anxiety and quality of life, treatment time and clinical efficiency, and overall cost. The investigators hypothesize that PROMISE will lead to a reduction in the percentage of patients ages 3-7 who require general anesthesia use from 70% (historical control) to 30%.

Key facts

Study ID

NCT05148078

Run by

University of Texas Southwestern Medical Center

People needed

30

Starts

2022-08-01

Expected to finish

2024-11-26

Last updated by the study team

2026-03-02

Who can join

Age: 3 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Planned to undergo radiation treatment
• Age 3-11 years
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at screening
• Parents or guardians with the ability to understand and the willingness to sign a written informed consent.

You may not qualify if…

• Subjects with documented medical behavior conditions or other conditions necessitating anesthesia use
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
• Subjects whose parents opt to not include them (the subject) in the clinical trial.

Where it is running

• UT Southwestern Medical Center Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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