Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE)

NCT05148078 | Completed Phase 2 Results DMC FDA Device

• 1 other identifier: STU-2021-1005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Pediatric Cancer

Keywords

radiotherapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Pediatric Patients Age 3-7 Who Require Daily General Anesthesia for All Treatments

  To change the total number of pediatric patients who require general anesthesia through the use of PROMISE.

  30 days

Secondary Outcomes (3)

• Patient- and Family-reported Health Quality of Life (QOL)

  From baseline to 30 days (+/- 14 days) after treatment termination (treatment length varied from 1 to 30 fractions)

• Patient Reported Anxiety by Family

  From baseline through 30 days (+/- 14 days) after treatment termination (treatment length varied from 1 to 30 fractions)

• Patient Movement

  Data was collected at each treatment session throughout treatment (treatment length varied from 1 to 30 fractions)

Study Arms (1)

General Anesthesia Decrease use : PROMISE

EXPERIMENTAL

To decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE

Other: PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect)

Interventions

PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect) OTHER

Pediatric Radiation Oncology with Movie Induced Sedation Effect (PROMISE) is an interactive, incentive-based movie system that integrates with a video surveillance gating module (VisionRT) to help keep a child's attention and prevent him or her from moving during radiation treatment. This technology is being studied as an alternative sedation solution for pediatric patients needing radiation treatment. As part of the trial, patients will be attempted to have CT simulation scan and first radiation treatment(s) using PROMISE, with general anesthesia on standby should PROMISE be unsuccessful. If PROMISE is unsuccessful for a given patient, then standard of care general anesthesia will be used for that patient's radiation treatment and PROMISE will be reattempted at physician discretion with anesthesia on standby.

General Anesthesia Decrease use : PROMISE

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Kiran Kumar, MD
• Organization: University of Texas Southwestern Medical Center

Kiran.Kumar@UTSouthwestern.edu

214/645-0908

Study Officials

• Kiran A Kumar, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: December 8, 2021
• Study Start: August 1, 2022
• Primary Completion: October 14, 2024
• Study Completion: November 26, 2024
• Last Updated: March 2, 2026
• Results First Posted: March 2, 2026

Record last verified: 2026-02

Locations

US (1)