Trismus exercise adherence during radiotherapy

Restorabite is a trismus treatment device patent filed PCT/AU2022/050474 Participants will be randomised into three groups to assess the effectiveness of the adherence protocol in different exercise regimens - control, intervention 1 and intervention 2: Intervention 1: Restorabite exercises regimen involving the lowest intensity stretch (the patient will be asked to use the lowest intensity which still achieves a stretch) for a long duration once per day for up to 12.5 minutes per day. This will be achieved by asking the participant to place the restorabite between upper and lower dentition or gums. The force will be selected based on the minimum intensity that the participant can perceive a stretch. They will keep the restorabite in their mouths for a maximum of 12.5 minutes per day. Intervention 2: Restorabite exercises regimen involving the highest intensity stretch that they can manage for a short duration. This will be achieved by asking the participant to place the restorabite between upper and lower dentition or gums. The force will be selected based on the maximum intensity that the participant can tolerate without causing pain. They will keep the device in their mouth for the same amount of time as the standard care group All: All participants in intervention groups 1 and 2 receive standard of care + interventions. Semi structured interview will be held to determine facilitators and barriers to preventative trismus exercises. The interviews will be conducted by investigators , independent of the treating clinicians. They will be offered in person, phone or online via Zoom or Microsoft Teams. If the participant elects to do this in person it can be arranged to coincide with a routine post-treatment review at the conclusion of their treatment. The computerised speech lab will be used to record the interviews. Standard care refers to outcome measures already taken as part of routine practice, ‘study specific’ refers to those taken specifically for the purpose of this trial. All measures will be collated before starting radiotherapy, weekly during radiotherapy including last week of radiotherapy, 2 weeks, 3-, 6-, and 12- months post-radiotherapy, with exception of adherence reminders which will be sent daily for the 6-week duration of the radiotherapy therapy. Following is the standard care: Patients undergoing therapy are screened from the head and neck multidisciplinary team meeting and the weekly radiation therapy spreadsheet which is collated and distributed by the radiation oncology registrar. Patients are contacted by phone to organise an initial assessment and education session prior to commencing radiotherapy with Speech Pathology and Nursing. Initial speech pathology consult to assess swallow, mouth opening and trismus. This involves a measure of maximal mouth opening and mucositis scoring, and prescription of exercises including mouth opening and detection of minimum detectable force (measured in newtons) Weekly appointments during radiotherapy (6 weeks) with the speech pathologist providing rehabilitation and support for speech, voice, swallowing and trismus. This includes general discussion about adherence to exercises and encouragement to complete them. Mucositis and MMO scoring Follow up visits at 2 weeks, 4 weeks, 3-, 6- and 12-months post-radiation with the speech pathologist providing rehabilitation and support for speech, voice, swallowing and trismus. This includes general discussion about adherence to exercises and encouragement to complete them. Following are the study specific steps when compared to standard care (above): Study investigators will contact the patient’s surgeon and/or radiation oncologist to seek clearance to commence Restorabite trismus exercises during radiotherapy. Potential participants will be informed of the study and invited to participate by one of the study investigators. They will have a minimum of 24 hours to consider their response. Their decision will have no effect on their clinical care. They will be assured that participation is entirely voluntary. In addition to usual initial speech pathology consult, potential participants will be given a patient information sheet and consent form, and have the study explained to them by senior study investigator. This will include a discussion of all risks, benefits and alternatives to being involved. If they are willing to participate, they will sign a consent form. They will be given a signed copy of the patient information and consent form. With this will also be a withdrawal form should they chose to discontinue with the study at any time. Those who do not wish to participate will carry on with standard care treatment. In addition to the routine weekly appointments during radiotherapy they will receive daily texts via Lifehouse installation of REDCap to remind about trismus exercises. Weekly reviews will also include 12 item GTQ and adverse event reporting Follow up visits will also include the 12-item GTQ and adverse event reporting Participants will be invited to complete an interview with a study investigator as to the facilitators and barriers to adhering to the trismus program. Participants in the intervention groups will use the intervention for 12 months post radiotherapy with the secondary objective of this trial to check adherence to intervention.