Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE)
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ClinicalTrials.gov Identifier: NCT05148078 |
Recruitment Status :
Recruiting
First Posted : December 8, 2021
Last Update Posted : December 19, 2023
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Condition or disease | Intervention/treatment | Phase |
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Pediatric Cancer | Other: PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE): A Phase II Clinical Trial to Safely Reduce Anesthesia Use |
Actual Study Start Date : | August 1, 2022 |
Estimated Primary Completion Date : | August 2024 |
Estimated Study Completion Date : | September 2024 |
Arm | Intervention/treatment |
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Experimental: General Anesthesia Decrease use : PROMISE
To decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE
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Other: PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect)
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. |
- Percentage of pediatric patients age 3-7 who require daily general anesthesia for all treatments [ Time Frame: 30 days ]To change the total number of pediatric patients who require general anesthesia through the use of PROMISE.
- Patient-reported health quality of life (QOL) [ Time Frame: 30 days (+/- 14 days) after treatment termination ]Patient-reported health quality of life is assessed using Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module. It is a 5-point Likert scale from 0 (never) to 4(almost always) and the scores are transformed to a 0 to 100 scale, with higher scores indicating a better health-related quality of life.
- Family-reported health quality of life [ Time Frame: 30 days (+/- 14 days) after treatment termination ]Family-reported health quality of life is assessed using Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module. It is a 5-point Likert scale from 0 (never) to 4(almost always) and the scores are transformed to a 0 to 100 scale, with higher scores indicating a better health-related quality of life.
- Patient reported anxiety [ Time Frame: 30 days (+/- 14 days) after treatment termination ]Patient reported anxiety is measured by the modified Yale Preoperative Anxiety Survey Short Form (mYPAS-SF).The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal). Behavior is rated from 1 to 4 or 1 to 6 (depending on the item), with higher numbers indicating the highest severity within that item (i.e, high levels of anxiety).
- Family reported anxiety [ Time Frame: 30 days (+/- 14 days) after treatment termination ]Family reported anxiety is measured by the modified Yale Preoperative Anxiety Survey Short Form (mYPAS-SF).The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal). Behavior is rated from 1 to 4 or 1 to 6 (depending on the item), with higher numbers indicating the highest severity within that item (i.e, high levels of anxiety)
- Patient Movement [ Time Frame: 30 days (+/- 14 days) after treatment termination ]To determine the average patient movement and beam stoppages with PROMISE
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Ages Eligible for Study: | 3 Years to 11 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05148078
Contact: Jonathan VanPelt | 214-645-8465 | jonathan.vanpelt@utsouthwestern.edu | |
Contact: Sarah Neufeld | 214-645-8465 | sarah.hardee@utsouthwestern.edu |
United States, Texas | |
UT Southwestern Medical Center Dallas | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Sarah Neufeld 214-645-8525 sarah.hardee@utsouthwestern.edu |
Principal Investigator: | Kiran A Kumar, MD | UT Southwestern Medical Center |
Responsible Party: | Kiran Kumar, Assistant Professor, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT05148078 |
Other Study ID Numbers: |
STU-2021-1005 |
First Posted: | December 8, 2021 Key Record Dates |
Last Update Posted: | December 19, 2023 |
Last Verified: | December 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
radiotherapy |