Trial Outcomes & Findings for Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE) (NCT NCT05148078)
NCT ID: NCT05148078
Last Updated: 2026-03-02
Results Overview
To change the total number of pediatric patients who require general anesthesia through the use of PROMISE.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
30 days
Results posted on
2026-03-02
Participant Flow
Participant milestones
| Measure |
General Anesthesia Decrease Use : PROMISE
To decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE
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.
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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26
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
General Anesthesia Decrease Use : PROMISE
To decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE
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.
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Overall Study
Death
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1
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Overall Study
Withdrawal by Subject
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3
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Baseline Characteristics
Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE)
Baseline characteristics by cohort
| Measure |
General Anesthesia Decrease Use : PROMISE
n=30 Participants
To decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE
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.
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|---|---|
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Age, Customized
3 to 7
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24 Participants
n=41 Participants
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Age, Customized
8 to 11
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6 Participants
n=41 Participants
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Sex: Female, Male
Female
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18 Participants
n=41 Participants
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Sex: Female, Male
Male
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12 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=41 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=41 Participants
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|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=41 Participants
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|
Race (NIH/OMB)
Black or African American
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3 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
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21 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=41 Participants
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PRIMARY outcome
Timeframe: 30 daysTo change the total number of pediatric patients who require general anesthesia through the use of PROMISE.
Outcome measures
| Measure |
General Anesthesia Decrease Use : PROMISE
n=24 Participants
To decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE
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.
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Percentage of Pediatric Patients Age 3-7 Who Require Daily General Anesthesia for All Treatments
Percentage of participants who were able to successfully use PROMISE for all RT treatments
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88 percentage of participants
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Percentage of Pediatric Patients Age 3-7 Who Require Daily General Anesthesia for All Treatments
Percentage of patients who required anesthesia for one or more treatments
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12 percentage of participants
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SECONDARY outcome
Timeframe: From baseline to 30 days (+/- 14 days) after treatment termination (treatment length varied from 1 to 30 fractions)Patient- and 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. The parent assessment is the parents' or caretakers' assessment of the patients' quality of life. The patient assessment is the patients' self-assessed quality of life. Patients (optionally per protocol) and parents/caretakers (required per protocol) completed questionnaires at baseline, once per week during treatment, and at the 1M follow up visit.
Outcome measures
| Measure |
General Anesthesia Decrease Use : PROMISE
n=24 Participants
To decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE
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.
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Patient- and Family-reported Health Quality of Life (QOL)
Patient score baseline
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66.27 score on a scale
Standard Deviation 17.86
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Patient- and Family-reported Health Quality of Life (QOL)
Average patient score throughout treatment
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77.07 score on a scale
Standard Deviation 17.18
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Patient- and Family-reported Health Quality of Life (QOL)
Patient score at 1M follow up
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75.32 score on a scale
Standard Deviation 14.10
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Patient- and Family-reported Health Quality of Life (QOL)
Parent score baseline
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72.50 score on a scale
Standard Deviation 13.95
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Patient- and Family-reported Health Quality of Life (QOL)
Average parent score throughout treatment
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76.77 score on a scale
Standard Deviation 12.39
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Patient- and Family-reported Health Quality of Life (QOL)
Parent score at 1M follow up
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78.92 score on a scale
Standard Deviation 11.86
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SECONDARY outcome
Timeframe: From baseline through 30 days (+/- 14 days) after treatment termination (treatment length varied from 1 to 30 fractions)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). Scores are calculated based on responses, with scores ranging from 23 to 100, with higher scores indicating higher anxiety (worse outcome). This is one questionnaire and is not separated by patient and family- the patient's parents or caretakers assess and report the patient's anxiety. Patients (optionally per protocol) and parents/caretakers (required per protocol) completed questionnaires at baseline, once per week during treatment, and at the 1M follow up visit.
Outcome measures
| Measure |
General Anesthesia Decrease Use : PROMISE
n=24 Participants
To decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE
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.
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|---|---|
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Patient Reported Anxiety by Family
Baseline scores
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29.19 score on a scale
Standard Deviation 8.48
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Patient Reported Anxiety by Family
Follow up scores
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23.55 score on a scale
Standard Deviation 4.45
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SECONDARY outcome
Timeframe: Data was collected at each treatment session throughout treatment (treatment length varied from 1 to 30 fractions)To determine the average patient movement with PROMISE; patients shift position during treatment, this outcome measure is looking at the average amount of movement, in millimeters, patients had while undergoing treatment with PROMISE. Data was collected at each treatment session (fraction) throughout treatment. Treatment length for each patient was dependent on their individual diagnosis and therefore varied from 1 to 30 fractions. An average was then calculated from all of the treatment fractions for all patients.
Outcome measures
| Measure |
General Anesthesia Decrease Use : PROMISE
n=24 Participants
To decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE
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.
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Patient Movement
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1.34 millimeters
Standard Error 0.86
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Adverse Events
General Anesthesia Decrease Use : PROMISE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kiran Kumar, MD
University of Texas Southwestern Medical Center
Phone: 214/645-0908
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place