TELE-CONNECT: Telehealth Exercise for Continence After Gynaecological Cancer Treatment

Pelvic floor muscle training (PFMT) + home exercise program + non-exercise components. Pelvic floor muscle training (PFMT) intervention: 'What' The intervention: 8 x 30-60 minute telehealth sessions over 16 weeks (e.g. at 1, 2, 4, 6, 8, 10, 13 & 16 weeks). The initial consultation will be 60 minutes, consultations 2 - 7 will be 30 minutes and consultation 8 will be 45 minutes in order to provide all elements of the intervention at the appropriate time. 'Who' The provider: Physiotherapist with postgraduate training in pelvic floor physiotherapy. Per-protocol study training: detailed study manual and training in study processes and procedures, designed specifically for this study, including: pelvic floor muscle (PFM) assessment and exercise instruction processes; instructions for teaching use of the biofeedback device (device name: 'femfit®'); biofeedback data export; practice video-consultations to practice video-consultation skills. In the 8 weeks before the first participant is enrolled, physiotherapists will undergo protocol training, using live face to face and online training, supplemented by supply of all required resources and standard operating protocols. During the study: regular meetings with the research team to review per-protocol procedures to ensure adherence to standardised training protocols. 'How' Group or individual: Individual telehealth-delivered instruction in PFMT. The woman will receive the telehealth and home exercise program in her home. The femfit’s® pre-determined, starting level and exercise program will be used. The starting level may be modified and additional tailoring to each woman may also be recommended by the treating study physiotherapist based on assessment findings. Supervision: Individually-supervised remotely via telehealth. Between telehealth consultations women will complete their PFMT unsupervised, 5 days per week. After randomisation and before their first telehealth consultation each intervention group participant will receive by registered post a participant study manual that will include: - a welcome letter describing their involvement in the study and listing all study resources that they will have received - detailed instructions of how to use the telehealth Zoom Cloud Meetings software (Zoom) for physiotherapy consultations - information regarding good bladder and bowel health (same as control group) and participant diaries (e.g. exercise and accident diaries) - detailed instructions of how to use the femfit® biofeedback device and associated smartphone app - a femfit® biofeedback device to help teach the correct PFM contraction technique, to monitor PFM strength gains during telehealth consultations and home practice, and facilitate PFMT adherence - prior to participant's first physiotherapy consultation, a member of the research team will schedule a Zoom consultation with the participant, to ensure they are able to connect successfully for their physiotherapy consultations. Adherence to exercise measures: Adherence to PFMT will be recorded within the femfit® app. The participant can elect to have daily reminders sent ('pushed') to her phone to remind her to do her exercises once a day at a time selected by the participant; this setting is available in the app. Attendance at physiotherapy consultations will be recorded by the physiotherapist. Motivation strategies: Biofeedback will be provided via the femfit® device and associated app. Biofeedback is provided to the participant via a visual display of the pressure profile created by the participant's pelvic floor muscle contraction, relative to a target pressure line that the participant aims to match. This pressure profile is only visible to the participant when she is performing her pelvic floor muscle exercises using the sensor and the app. In addition, physiotherapists will draw from an extensive list of behaviour change motivational strategies according to the woman's needs. Example strategies may include goal setting, specific instructions/wording on how to perform PFMT, verbal persuasion, visual cues. Progression: The femfit’s ® pre-determined, exercise program and recommended progressions will be used which are evidence-based and clinically validated. Within the femfit® app the intensity and repetitions of the exercises increase every 4 weeks. In the first month, the exercise program will take around 8 minutes to complete daily. This increases to 12 minutes in the second month, 16 minutes in months 3 and 4. The participant will then enter a maintenance phase with exercises performed 3 times per week until 52 weeks. The position to do the exercises also changes from lying to supported standing, to standing. Detailed description of exercise session: PFM exercises included in the femfit ® training program are: maximal contraction, co-ordination, endurance, contraction with cough. These will be described in the femfit® app as “Squeeze”, “Rapid”, “Enduro”, and “Knack”. Home program: PFM exercises, as prescribed by the physiotherapist, will be conducted by the woman at her home. Specific home exercise details regarding position, time, dosage, effort and use of the femfit® app will be provided by the physiotherapist at each consultation. Non-exercise components: Intervention participants will receive the same informational handouts regarding good bladder and bowel health as the usual care group. Additional information will be provided as indicated: - For urinary urgency and frequency or urge urinary incontinence: bladder training including urinary urge suppression techniques, education on fluid intake modification including caffeine reduction if relevant, and education in good bladder and bowel habits. - For faecal incontinence: bowel routine training, education on dietary fibre including psyllium supplementation, education on faecal urgency suppression techniques.