A Phase 2 interventional study of PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect) in Pediatric Cancer, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 3 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by University of Texas Southwestern Medical Center · Phase 2, Interventional, and Supportive care
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%.
Radiation therapy (RT) requires precise immobilization in order to accurately deliver a conformal dose to the target(s) while avoiding nearby organs at risk. In children, RT frequently requires daily anesthesia use during the entire course of treatment, often up to 4-6 weeks total. While the data varies, \~40-50% of children, and the majority of those under the age of 7, require daily general anesthesia. Anesthesia can have significant short- and long-term detrimental effects on patient health, including increased risk of hypoxia, allergic reactions, hyperthermia, vascular access device complications (20-25%), and neurocognitive impairment. Furthermore, daily anesthesia provides significant logistical and financial burden, with the average 6-week course of daily anesthesia for RT being approximately $50,000 in payer charges.
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 children's attention and prevent children from moving during radiation treatment. While audiovisual distraction techniques have previously been described, PROMISE is the first system that allows for real time monitoring of patient motion and automatic shutting off of the beam and video if the patient moves outside of defined parameters. This not only provides a built-in safety mechanism, but also allows for real time behavior training that incentives patients to not move.
The investigators propose implementing PROMISE for all children between ages 3-11 undergoing radiation treatment through a phase II clinical trial with the following workflow: 1) During the CT simulation scan, a training session will be conducted, where the child will learn to lie still with positive and negative feedbacks provided by the system for behavioral training. This session will also be used as a screening test to choose children suitable for PROMISE. Only children meeting the movement-requirements during the training session will be selected as candidates for the following non-sedated radiation treatment. 2) During the treatment, a child will watch an age-appropriate movie or video of participant/s choice. A 3D surface imaging system will be used to monitor the motion of the child. If the motion exceeds any pre-defined positioning thresholds (e.g., conventional radiotherapy (CRT): 0.5 cm in translation movements and 2° in three rotational angles; stereotactic radiotherapy (SBRT): 0.15 cm and 0.5 degree), the treatment beam will be shut off and the movie will be paused. 3) Beyond threshold movements the child will be instructed with the effectiveness of movement control strategy. 4) If the child reverts to treatment position within a pre-defined temporal threshold (e.g. 1 minute), the treatment will be resumed with a continuing movie. 5) If the child cannot revert to the treatment position within a pre-defined time threshold/or the movement is beyond any pre-defined re-alignment threshold value (e.g., 1 cm / 5° in three rotational angles), the radiation beam and the movie will be turned off, the patient will be readjusted and the treatment will resume. 6) In any treatment fraction, PROMISE treatment will be ceased if therapists have to re-position the child multiple times. If the child is consecutively noncompliant with PROMISE treatments for two fractions, participant will receive radiotherapy treatment with general anesthesia for all subsequent fractions, unless instructed by physician to re-attempt PROMISE.
The primary objective is to decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE. The secondary objectives are to assess the impact that PROMISE has on patient/family anxiety and quality of life, treatment time and clinical efficiency, and overall cost, and to determine the average patient movement and beam stoppages with PROMISE. Patient/family-reported health quality of life will be assessed using PedsQL 3.0 Cancer Module and patient anxiety will be measured by the modified Yale Preoperative Anxiety Survey Short Form (mYPAS-SF).
The hypothesis is 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%. Using a two-sided exact binomial test with a significance level of 0.05 and power=80%, a sample size of 13 patients (ages 3-7) will be needed to detect this difference. In the investigator's past experience, \~42% of children ages 3-11 (eligibility criteria) are between 3-7 years old, so 30 children total will be needed to enroll 13 who are between 3-7 years old.
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Exclusion Criteria:
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)
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
To change the total number of pediatric patients who require general anesthesia through the use of PROMISE.
Time frame: 30 days
Patient- and Family-reported Health Quality of Life (QOL)
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.
Time frame: From baseline to 30 days (+/- 14 days) after treatment termination (treatment length varied from 1 to 30 fractions)
Patient Reported Anxiety by Family
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.
Time frame: From baseline through 30 days (+/- 14 days) after treatment termination (treatment length varied from 1 to 30 fractions)
Patient Movement
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.
Time frame: Data was collected at each treatment session throughout treatment (treatment length varied from 1 to 30 fractions)
| Milestone | General Anesthesia Decrease Use : PROMISE |
|---|---|
| Started | 30 |
| Completed | 26 |
| Not completed | 4 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal by subject | 3 |
To change the total number of pediatric patients who require general anesthesia through the use of PROMISE.
| percentage of participants | General Anesthesia Decrease Use : PROMISE |
|---|---|
| Percentage of participants who were able to successfully use PROMISE for all RT treatments | 88 |
| Percentage of patients who required anesthesia for one or more treatments | 12 |
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.
| score on a scale | General Anesthesia Decrease Use : PROMISE |
|---|---|
| Patient score baseline | 66.27 ± 17.86 |
| Average patient score throughout treatment | 77.07 ± 17.18 |
| Patient score at 1M follow up | 75.32 ± 14.10 |
| Parent score baseline | 72.50 ± 13.95 |
| Average parent score throughout treatment | 76.77 ± 12.39 |
| Parent score at 1M follow up | 78.92 ± 11.86 |
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.
| score on a scale | General Anesthesia Decrease Use : PROMISE |
|---|---|
| Baseline scores | 29.19 ± 8.48 |
| Follow up scores | 23.55 ± 4.45 |
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.
| millimeters | General Anesthesia Decrease Use : PROMISE |
|---|---|
| Patient Movement | 1.34 ± 0.86 |
Collected over Adverse events and serious adverse events were not collected for this study, per protocol. All-cause mortality was monitored throughout treatment and for 1 month after treatment completed. Patients had different lengths of treatment depending on their individual diagnosis, so the total time varied from approximately 5 weeks (treatment and follow up) to approximately 11 weeks (treatment and follow up).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| General Anesthesia Decrease Use : PROMISE | 1/30 (3.3%) | — | — |
| Age, Customized(Participants) | General Anesthesia Decrease Use : PROMISE |
|---|---|
| 3 to 7 | 24 |
| 8 to 11 | 6 |
| Sex: Female, Male(Participants) | General Anesthesia Decrease Use : PROMISE |
|---|---|
| Female | 18 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | General Anesthesia Decrease Use : PROMISE |
|---|---|
| Hispanic or Latino | 15 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | General Anesthesia Decrease Use : PROMISE |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 21 |
| More than one race | 0 |
| Unknown or Not Reported | 5 |
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University of Texas Southwestern Medical Center