JMIR Publications

ABSTRACT

Background:

Pediatric cancer patients have limited options to self-manage their health while they are undergoing treatments in the hospital and after they are discharged to their homes. Extended reality using head-mounted displays has emerged as an immersive method of improving pain, mental health, and promoting health-enhancing physical activity among a variety of clinical groups, but there is currently no established protocol for improving both physical and mental health in pediatric cancer rehabilitation.

Objective:

This phase I pilot feasibility randomized controlled trial aims to investigate the potential effects of a 14-week extended reality program on physical activity participation and indicators of health among pediatric cancer patients who undergo bone marrow transplantation. An ancillary aim is to evaluate the feasibility of the program via participant engagement.

Methods:

This study includes a two-armed parallel group design with a one-group crossover (control group will start intervention after a wait period). Sixteen pediatric cancer rehabilitation patients (aged ≥8 years) at a Children’s Hospital will be randomly allocated into one of two groups: an immediate start group that undergoes an extended reality program in the hospital until discharge and then for 8 weeks at home (total duration of ~14 weeks), and a waitlist control group that undergoes usual care in the hospital and for 8 weeks at home, prior to receiving the 8-week home extended reality program. The program will include active video gaming with rhythmic music exercises as well as mindfulness-based practices using a high-quality application. Home-based programming will include behavioral coaching calls. Physical activity will be measured daily via step counts using a tri-axial accelerometer. Health outcomes will be measured across time and include global health, measured by the NIH PROMIS Pediatric Global Health Scale Short Form 7+2, and lung function, measured by a forced expiratory volume using a peak flow meter. Feasibility will be evaluated through participant engagement metrics: enrollment, dropout, adverse events, and attendance rates.

Results:

Recruitment procedures started on June 27th, 2024. All data are anticipated to be collected by February 2026. Full trial results are anticipated to be analyzed and submitted for publication by March 2026.

Conclusions:

This trial tests an accessible remote program for improving both physical and mental health among pediatric cancer patients. The knowledge obtained from this study will inform the development of a larger trial. Clinical Trial: NCT06298357