NCT05148078

Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE)

Completed Phase 2 Results posted Last updated 2 March 2026

What this trial tests

Phase 2 trial testing PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect) in Pediatric Cancer in 30 participants. Completed in 26 November 2024.

Timeline

1 August 2022

Primary endpoint
14 October 2024

26 November 2024

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	30
Start date	1 August 2022
Primary completion	14 October 2024
Estimated completion	26 November 2024
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Pediatric Cancer — all drugs for Pediatric Cancer →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 3 to 11, any sex, with Pediatric Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Pediatric Patients Age 3-7 Who Require Daily General Anesthesia for All Treatments Primary · 30 days

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

Percentage of participants who were able to successfully use PROMISE for all RT treatments

Group	Value	95% CI
General Anesthesia Decrease Use : PROMISE	88

Percentage of patients who required anesthesia for one or more treatments

Group	Value	95% CI
General Anesthesia Decrease Use : PROMISE	12

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

Patient score baseline

Group	Value	95% CI
General Anesthesia Decrease Use : PROMISE	66.27	± 17.86

Average patient score throughout treatment

Group	Value	95% CI
General Anesthesia Decrease Use : PROMISE	77.07	± 17.18

Patient score at 1M follow up

Group	Value	95% CI
General Anesthesia Decrease Use : PROMISE	75.32	± 14.10

Parent score baseline

Group	Value	95% CI
General Anesthesia Decrease Use : PROMISE	72.50	± 13.95

Average parent score throughout treatment

Group	Value	95% CI
General Anesthesia Decrease Use : PROMISE	76.77	± 12.39

Parent score at 1M follow up

Group	Value	95% CI
General Anesthesia Decrease Use : PROMISE	78.92	± 11.86

Patient Reported Anxiety by Family Secondary · 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 patie

Baseline scores

Group	Value	95% CI
General Anesthesia Decrease Use : PROMISE	29.19	± 8.48

Follow up scores

Group	Value	95% CI
General Anesthesia Decrease Use : PROMISE	23.55	± 4.45

Patient Movement Secondary · 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.

Group	Value	95% CI
General Anesthesia Decrease Use : PROMISE	1.34	± 0.86

Sponsor's own description

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%.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.