A recent study found that PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect) resulted in a 30 percent absolute reduction in general anesthesia use for children ages 3-7. These findings were recently presented during a press briefing at the American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract 179).
Radiation therapy requires precise immobilization to ensure safe and accurate treatment, according to study author Jeffrey T. Chapman, BS, a medical student at the UT Southwestern Medical Center, who noted that this can be a challenge when caring for pediatric patients.
The current solution to this problem is general anesthesia; however, repeated anesthesia can negatively impact patient health and quality of life in addition to logistical and financial burdens. Recognizing this issue, Chapman and colleagues asked the question: "Is there a better way to help children stay still during their treatments?" The answer was PROMISE, an interactive, incentive-based movie system that allows for real-time monitoring of a patient's motion.
Study Details
The researchers hypothesized that PROMISE would result in minimal patient movement during radiation therapy and an overall decrease in the need for general anesthesia in young children ages 3-7.
"PROMISE integrates a movie system involving wireless video streaming to a low attenuation screen directly in front of the patient with a video surveillance gating module (AlignRT) for real-time monitoring and behavior training," said Chapman and colleagues. "Starting in the beginning of 2020, this system was available for all children younger than 12 years old undergoing radiation therapy at our institution."
The beam as well as video automatically shuts off if the patient moves outside of defined parameters, explained Chapman, while emphasizing the importance of this feature to guarantee the safety of their patients.
Investigators collected and analyzed the AlignRT monitoring data from patients treated with PROMISE to determine patient motion. To estimate the reduction in anesthesia use per age group, they compared frequency of anesthesia use after implementation of PROMISE to the 2 years prior at their institution.
PROMISE was successfully implemented in 21 children. The majority (76%) were 7 years or younger and most likely would have otherwise required daily anesthesia, according to the study authors. "Patient movement during radiation therapy with PROMISE was minimal, with in-treatment variation of approximately 1.2 mm (0.8 mm standard deviation) from the reference baseline," they noted.
Prior to implementation of PROMISE (2018-2019), Chapman reported that 100 percent of children below the age of three (6/6), 70 percent of those ages 3-7 (14/20), and 14 percent ages 8-11 (4/28) required general anesthesia. In comparison, after PROMISE was implemented in 2020, the data showed that 100 percent of pediatric patients below the age of 3 (5/5), 40 percent of children ages 3-7 (8/20), and 8 percent of those ages 8-11 (1/13) needed general anesthesia.
"When analyzed per fraction, after PROMISE, 100 percent below the age of 3 (76/76), 29 percent ages 3-7 (90/315), and less than 1 percent ages 8-11 (1/221) required general anesthesia," the study authors stated. "On per patient comparison, PROMISE resulted in a 30 percent absolute benefit in those 3-7 years old, with 70 percent previously requiring anesthesia to only 40 percent after the implementation of PROMISE.
"Further, patient movement during radiation therapy with PROMISE was minimal, within acceptable standards," they wrote. "The real-time motion monitoring with automatic safety shutoff and behavioral training make PROMISE a unique and attractive alternative to general anesthesia. Further prospective clinical data is necessary to prove the safety and efficacy of PROMISE in pediatric radiation therapy."
Significance & Next Steps
This study highlights the positive impact PROMISE can have on patients, especially when it comes to their radiation therapy experience.
The children arrive about 15 minutes before their treatment time, explained study author Kiran Kumar, MD, MBA, Chief of Lymphoma and Pediatrics Radiation Oncology Services at UT Southwestern Medical Center.
"They will choose their favorite movie or video they want to watch and then they'll lie down on the table and the screen will be directly in front of their face," he said, while noting that most children are happy to be there and excited to watch the video. This is very different compared to the experience without PROMISE, added Chapman, while reiterating the negative side effects of repeated anesthesia.
"Before PROMISE, 70 percent of kids ages 3-7 that came to the clinic required general anesthesia," Chapman emphasized. "Now that number is down to 40 percent; a 30 percent absolute reduction, which is huge. But, just as important, are the anecdotal findings from the parents and patients that we have seen so far.
"It has changed treatment experience for these kids and the parents as well. It is making a huge impact both statistically with the numbers and then individually, which I think is just as important," he concluded. "Moving forward, we have an upcoming Phase II clinical trial that will hopefully confirm our initial findings, so we can get PROMISE helping more kids."
Catlin Nalley is a contributing writer.