Pain, Pediatric Cancer
Conditions
Brief summary
In this SBIR, ALTality, Inc. (SpellBound) will assess the feasibility of a dual English/Spanish language augmented reality(AR)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in Hispanic/Latino children and adolescents with cancer in collaboration with bilingual Spanish-speaking anesthesiologists at the MD Anderson Cancer Center. If successful, the AR app will be an immediately implementable and commercially viable method of providing Hispanic/Latino pediatric cancer patients with limited English proficiency an adjunctive tool to overcome infrastructural barriers to receiving translation services in acute care settings that put them at higher risk of under and/or overtreatment of pain by prescription opioids and future prescription opioid dependency and misuse, at no cost to them or their families.
Interventions
DEVICEAR Pain assessment
Age-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration
Sponsors
M.D. Anderson Cancer Center
ALTality, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* ages 7-17 years old * child able to provide assent, and a legal guardian able to provide informed consent * current diagnosis of pediatric cancer * undergoing surgery for cancer treatment requiring postoperative inpatient hospitalization * prescribed or expected to be prescribed opioids during inpatient perioperative period * sufficient mental capacity to comprehend and interact with the game in English or Spanish.
Exclusion criteria
* the inability to play with the SpellBound app from English or Spanish instructions * daily opioid use within 30 days prior to surgery * any concerns from the treatment team.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary; Percent of enrolled patients who activated/used the app during the PACU stay | immediately after the intervention/procedure/surgery | Feasibility measured as activation/usage of the app recorded by the device ID for each patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recorded responses about pain assessment from the app | immediately after the intervention/procedure/surgery | Pain scale score in English or Spanish through the app |
| Recorded responses about nausea/vomit assessment from the app | immediately after the intervention/procedure/surgery | Baxter animated retching scale score in English or Spanish through the app |
| Inpatient opioid consumption | immediately after the intervention/procedure/surgery | Calculated as morphine equivalent dose of all opioids given |
| Total time spent playing on the AR app during the PACU stay | immediately after the intervention/procedure/surgery | Length of time (minutes) of app usage recorded by the device ID for each patient |
| Quality of life survey | immediately after the intervention/procedure/surgery | PedsQL survey administered to child and/or adult caregiver stratified by age |
| Rate of opioid prescription | immediately after the intervention/procedure/surgery | The percentage of patients with opioid prescriptions at the time of discharge from the electronic health record |
| Patient/caregiver satisfaction survey | immediately after the intervention/procedure/surgery | Asked to the patient/caregiver by the study team - 1) How satisfied were you with regards to your pain management in PACU?, 2) How satisfied were you with regards to your nausea management in PACU?, 3) How satisfied were you with the use of the AR app to help assess your pain and nausea? |
| Length of stay | immediately after the intervention/procedure/surgery | Total time (minutes) spent in the PACU after surgery |
Countries
United States
Outcome results
None listed