Optimising Adherence Pilot Program: Investigating the impact of a novel intervention on the incidence of trismus during radiotherapy for head and neck cancer patients

Restorabite, a new, class I medical device used for the treatment of trismus (restricted mouth opening) will be piloted in a preventative context for patients undergoing radiotherapy for head and neck cancer. This replaces traditional devices such as stacking tongue depressors and inserting between the teeth, or TheraBite. This trial will investigate how to best facilitate adherence to trismus exercises during radiotherapy. This pilot program will randomise participants into the standard care or intervention group. The intervention group will have a pre-radiation education session about trismus which will cover how to measure their mouth opening and their exercise program during radiation. It is anticipated to last 30 minutes of face-to-face time. It will occur at time of radiation planning approximately 2-3 weeks prior to radiation commencing. This information and education session involving verbal/physical instructions given by the speech pathologist is intended to improve the patient's understanding of trismus and independence monitoring and managing the condition. They will get daily text reminders to complete their exercises during radiotherapy treatment. Adherence to exercises and maximal mouth opening will be measured in both groups. This will be monitored using REDCap software delivery system and by the clinical manager who will monitor the data being collected. The maximum duration participants will received text messages is 6 weeks. Any participant who would prefer not to receive text messages will be offered use of a paper based exercise diary. The intervention groups will be taught how to carry out passive and active jaw range of motion exercises is a continuous exercise performed with Restorabite. It involves inserting the pressed down Restorabite between the teeth and letting the device stretch the jaw (passive motion exercise) then bite down on the mouth guards (active motion exercise). Their home practice will be a maximum of 15 minutes per day comprising of up to 60 second stretches, 10 repetitions, 5 sets per day. During the weekly reviews during radiotherapy the speech pathologist will measure the patient's mouth opening and review the exercises assigned to them, as well as manage any barriers encountered to exercise adherence. At the end of radiotherapy, patients will continue to exercise with Restorabite and monitoring their mouth opening independently, with ongoing assistance from speech pathology as required on a case by case basis.