An evaluation of early intervention using compression garments following neck dissection surgery for head and neck cancer and the impact on lymphoedema

Outcome Measurements (experimental and control group) will be taken at 4 time points: - T0 (baseline) will occur in the anaesthetic peri-operative clinic (APOC), or at a time prior to surgery. - T1 will occur in the post-operative outpatient clinic which occurs 1 to 2 weeks post discharge following neck dissection surgery (prior to, but on the day, of randomisation) - T2 will occur in the lymphoedema outpatient setting at 9 ± 2 weeks post discharge, prior to (on the same day of) the lymphoedema appointment. T2 is the primary timepoint. Outcome measurements for T2 will be completed by a blind assessor. All other outcomes timepoints are unblinded. - T3 will coincide with a routine medical follow-up appointment 24 weeks post-operatively. Experimental Group: Compression garments: At 1-2 weeks post discharge (T1), a Jobst chin strap or custom Jobskin face mask will be prescribed to the experimental (intervention) group. These are forms of compression garment for compression of a portion or all of the face and neck. Compression garments apply external pressure to the skin and soft tissue enhancing muscle contraction and skin movement which moves lymphatic fluid into and through the lymphatic vessels (Yoshihara et al., 2022). The Jobskin custom made face mask (compression garment) may be prescribed based on clinical need (e.g. if oedema is present anterior to the coverage of the ready-to-wear Jobst chin strap garment). If prescribed, one will be ordered and fitted. Once fit is confirmed, a second garment will be ordered. If no changes to the fit of the first garment are required, the second will be ordered and mailed directly to the participant. If adjustments to improve the fit of the custom garment are required, the participant may need to attend for an additional fitting. The Researcher will decide if the adjusted garment can be mailed or needs to be fitted in-person, depending on the extent of adjustment required. Based on the Researcher’s clinical assessment, a textured insert may be used with the compression garment. The type and coverage of the insert will be individual to the participant’s needs based on clinical assessment. This assists in softening thickened tissue when present and improves the efficacy of the pressure provided by the compression garment on the movement of lymphatic fluid. All compression garments will be prescribed by the Researcher (certified lymphoedema practitioner). Two garments will be provided (one to wash and one to wear) regardless of whether the garment is ready-to-wear (RTW i.e. Jobst Chin Strap) or custom-made (i.e. Jobskin). The garments will be free of charge to the participant, funded through the research project budget. The RTW compression garment fitting will take approximately 15 minutes for prescription of compression and education regarding application, wear time and care. For a custom garment, the measuring will take approximately 15 minutes and a subsequent fitting appointment will also take approximately 15 minutes. Where possible, the fitting appointment will coincide with other hospital appointments. Should the experimental group participant require a new garment due to change in sizing, at a time before they are seen in the lymphoedema outpatient clinic for a standard appointment, the participant will be prescribed a new size or custom garment based on clinical assessment. If a ready-to-wear Jobst chin strap is required, the participant may be able to be instructed on how to measure for the garment over video-consult or telephone call to prevent the need to attend clinic. If a custom garment is required, this will necessitate the need for the participant to attend clinic. Any additional garment provided to the participant will be provide free of charge. Participants in the experimental group will be educated on grading wear of the compression garment over 7 days from the time of prescription. Wear will be graded, commencing for short 15-30 minutes periods to ensure comfort, tolerance and fit, and then graded over the 7 days to wear at night (when sleeping i.e. 6-10 hours depending on sleep duration) and when completing head and neck exercises at home during the day. The head and neck exercises are prescribed as a part of standard care during the participants inpatient stay by either an Occupational Therapist, Physiotherapist or Speech Pathologist. Head and neck exercises include shoulder abduction/adduction, shrugs and rolls, neck exercises include flexion/extension and lateral flexion, mouth exercises include opening and closing the mouth, etc. The participant is allowed to wear the compression more frequently however must record this in their electronic diary (eDiary). This education will be provided at the time the garment is fitted with verbal instruction on grading, demonstration and practice of donning/doffing the garment and provision of a patient handout with written instructions. This will be reviewed at the followup videoconsult 1 week later (see videoconsultation below for further information). Video-consultation (VC): Following prescription of the compression garment, the experimental group will receive video-consultation, completed by the Researcher (lymphoedema-trained Occupational Therapist) 1, 3 and 6 weeks post randomisation i.e. post prescription of the compression garment. The video-consult will include clinical support to aid compression garment wear (e.g. grading, fit, barriers to wear). If clinically indicated a new compression garment of the appropriate size will be prescribed. Participants in the experimental group may contact the Researcher by phone if there are any concerns or difficulties with adherence to compression at any point up until initial assessment in the lymphoedema outpatient clinic (T2). Ad hoc consult frequency, duration, reason and action will be recorded in REDCap. Video and telephone-consultations will not be audio-recorded. All video-consult/phone consult discussions will be documented on REDCap. Only adverse events and the action taken will be recorded on the patient electronic medical record (BOSSnet). At 23 weeks post surgery, the participant will receive a phone call to remind them to complete the eDiary and of the research followup timepoint at 24 weeks post surgery. This is to assist attrition. Video-consultation is anticipated to be from 5-20 minutes in duration. eDiary: Patients will be provided with an electronic diary (via REDCap) to record adherence to all components of standard care + compression daily. If use of an electronic diary is not feasible for the participant, a paper-diary will be provided. The diary will be provided from inpatient discharge and completed until T1. A new diary will be provided from T1 to T2, then T2 to T3. From T2 to T3 the eDiary will be completed weekly rather than daily.