Title: Functional and quality of life change for patients undergoing treatments for recurrent oropharyngeal cancer and the impact on treatment decision making.
Funder: Health Education England

Abstract: The incidence of oropharyngeal cancer (OPC) in the UK has increased by 50% in the last 15 years. Despite treatment advances, recurrence rates remain high at 20-30%. The UK standard of care is open surgery, an intervention associated with high morbidity. Transoral robotic surgery (TORS) is now being considered as a minimally invasive option with encouraging oncological control. There may be opportunities for re-irradiation however this has the potential for severe treatment toxicity. Non-curative options include palliative systemic treatments or best supportive care. National guidance recommends that patients should be counselled on survival and functional outcome. However, functional data has not been reported systematically to allow its use to prepare patients, personalise care and inform service planning. Research Question: What is the trajectory of swallowing and communication change for patients undergoing treatments for recurrent OPC and how does this influence treatment decision-making? Study Aims: To systematically review the literature to identify functional outcomes and how they are measured in patients undergoing treatment for recurrent OPC. To explore patient and carer priority concerns regarding function and how these concerns influence treatment decision making in recurrent OPC. To report on functional outcomes for patients with recurrent OPC undergoing treatment.Methods for delivery: Systematic review of the literature identifying the functional outcomes and how these outcomes are measured for patients with recurrent OPC undergoing (1) open surgery (2) TORS (3) re-irradiation and (4) palliative systemic treatments. In-depth 1:1 interviews with patients with recurrent OPC and their carers to identify priority concerns regarding function and how these influenced treatment decision making. A single site prospective observational study using repeated measures, to investigate the speech and swallowing outcomes for adults who are treated for recurrent OPC at the Royal Marsden Hospital (RMH) with (1) open surgery (2) TORS (3) re-irradiation and (4) palliative systemic treatments. Baseline measures of speech and swallowing at point of recurrence diagnosis, and at 3, 6, and 12 months following surgery or into systemic treatment. Multi- dimensional outcome measures including patient reported, clinician rated measures of speech and swallowing and instrumental evaluation of swallowing will be used. The specific measures will be based on standard of care at our institution, national trials and the data obtained in work streams 1 and 2. Anticipated impact and dissemination: The acquisition of patient and carer experience and detailed longitudinal functional data will yield several benefits: For patients making decisions on treatments, these data will provide information on the potential impact of various treatment options on communication and swallowing. For service providers, these data will inform resource planning for rehabilitation as it will highlight the timing and nature of functional problems. This will inform the commissioning of services for optimised care pathways and a more holistic treatment plan encompassing optimal disease management and survivorship issues. This study will form the preliminary work for further studies including identifying the existing evidence, and will identify a theoretical understanding of the likely process of change in function.

Lay abstract: Approximately 9000 people diagnosed with head and neck cancer (HNC) are treated by the NHS every year. Oropharyngeal cancer (OPC), involving the tonsils and back of the tongue, is increasing. Treatments include radiotherapy, chemotherapy and surgery. OPC can have a devastating impact on communication and swallowing. Speech & Language Therapists (SLTs) assess, diagnose and treat communication and swallowing difficulties. The overall cure rate for OPC remains poor, with disease returning in approximately 20-30%. When the disease comes back, it is very difficult to treat. Usually, the only option which may offer cure is open surgery or a second course of radiotherapy. Open surgery involves cutting through the lip and jaw to remove the tumour. Complications such as poor healing, long hospital stays and chest infections due to unsafe swallowing (food or fluids entering the lungs on swallowing) are common. A second course of radiotherapy may be possible however as with surgery, this can cause great difficulty with speaking and swallowing and this can have a major impact on quality of life. Recently, robotic surgery has been introduced in a small number of hospitals. A robot (operated by a surgeon) is used to remove a tumour from the throat without cutting through the lip or jaw. Advantages include quicker healing, and better swallowing and communication. Sometimes, surgery is not possible if the person is too unwell, the tumour is too big or if the impact on swallowing and communication is predicted to be too great. People are offered palliative chemotherapy, experimental treatments, or best supportive care aiming not to cure but to slow down tumour growth and to keep the person comfortable. Aim: This study will look at changes in swallowing and communication over time in people with recurrent OPC and how these changes may impact treatment decision making. Design and methods: A systematic review of the literature to identify how changes in communication and swallowing are measured and reported in people with recurrent OPC. In depth interviews with people and their carers to explore priority areas of concern with regards to communication and swallowing and how these concerns may influence treatment decision making. An observational study measuring changes in communication and swallowing over time using (1) patient-reported questionnaires (2) clinician-reported rating scales and (3) an assessment of swallowing using a small camera/ scope placed in the throat (via the nose). Assessments will take place before treatment and at 3, 6 and 12 months after diagnosis. Further assessments will be included if specific areas of concern are highlighted in work stream 2.Participants: People diagnosed with recurrent OPC who are having surgery (open or robotic), radiotherapy or palliative chemotherapy and experimental treatments. Setting: The Royal Marsden Hospital NHS Foundation Trust. Patient and public involvement: This application has been reviewed by the Patient and Carer Research Advisory Group at the Royal Marsden NHS Foundation Trust, a trial steering group involving two patient representatives, the Swallows Charity, and the Research Design Service proposal feedback panel which includes lay members. The research was described as 'worthwhile' and the findings would 'help with patient decision making'. Dissemination: The acquisition of data in this study will yield several benefits: For people making decisions regarding their treatment options, these data will provide information regarding the likely changes in communication and swallowing with different treatments For service providers, the data will inform resource planning for rehabilitation input and will contribute to a more holistic treatment planning and provision For future research these data will inform the development of larger studies comparing treatments which are available with a focus on communication and swallowing difficulties.

Research activity codes: 7.2 END OF LIFE CARE;7.3 MANAGEMENT AND DECISION MAKING
Health categories: CANCER AND NEOPLASMS