Award Title: Pre-habilitation of swallowing difficulties in people with head and neck cancer: A pilot cluster randomized trial.
Funder: Health Education England

Abstract: Research Question for future main trial (PICOT):Do people with head and neck cancer who participate in a complex pre-habilitation behaviour change intervention tailored to educate, counsel and facilitate swallowing exercises over and above routine usual care achieve better dysphagia related quality of life at six months, compared with usual care? Background and main aims for the current pilot study:Difficulty in swallowing or dysphagia is the major issue affecting the long-term health and health related quality of life in people treated for head and neck cancer. A systematic and theoretically-derived pre-habilitation swallowing intervention package comprising psychological support, education and targeted exercises provided before cancer treatment was developed for people with head and neck cancer. The primary aims of this external pilot study are to test the feasibility of a cluster-randomized design and to explore the research processes via a small-scale version of the intended future main trial. Methods and analysis:This two-arm cluster randomized pilot trial will aim to recruit six hospital sites providing multidisciplinary head and neck cancer care. Hospitals will be randomized in a 1:1 ratio and allocated to 'usual care' and 'usual care plus intervention' groups. Usual care consists of the patient meeting a speech and language therapist prior to treatment for general information on side-effects and impact of treatment on swallowing. An exercise leaflet will also be offered. The pre-habilitation intervention comprises: an x-ray swallow assessment, tailored information, personalized exercises and specific strategies to enhance patient activation and engagement. People invited to participate in both groups will be: newly diagnosed with head and neck cancer (Stage II-IV), planned for treatment via one of the conventional modalities of surgery, radiotherapy (+/- chemotherapy), at least 18 years of age, and able to consent to participation. The target recruitment is approximately 12 patients from each hospital over a 6-month period (total n=72). Follow-up will be 6-months after completion of the final oncological treatment. A range of clinical, patient reported and instrumental measures of swallowing will be collected, and the primary outcome will be confirmed. Both quantitative and qualitative methods will be used for the analysis. Important parameters such as recruitment, retention, missing data will be estimated using proportions and 95% confidence intervals. Calculation of sample size will be made incorporating cluster variability (ICC) and clinically meaningful differences in the primary outcome. Process evaluation studies have been built into this pilot work at pre-trial, during trial and post-trial phases. These studies will use qualitative methods to explore:	Barriers and facilitators around context and implementation within each site that may impact the main trial. 	The level of intervention fidelity (delivery by clinicians) achieved during the pilot study, and the feasibility and acceptability of the methods used to determine intervention fidelity. 	Acceptability to clinicians and patients around participation in the trial, and the intervention itself.Main research output:At the end of this pilot study, the plan for a finalized design and optimized research process will be available to apply for funding of the main trial investigating clinical and cost-effectiveness.

Lay Abstract: Aim of the research:Most people with cancer in the mouth or throat (head and neck cancer) will have some difficulty in swallowing food and drink at some stage before, during and/or after cancer treatment. Dysphagia (difficulty in swallowing) may persist for months or years after treatment due to side-effects of surgery and chemo/radiotherapy.The aim of this research is to determine whether a pre-treatment swallowing intervention package improves patients' ability to eat and drink thus increasing their quality of life. The intervention comprises multiple components collectively called 'pre-habilitation.' This includes: tailored information, educational counseling, personalized exercises, and specific strategies to help engage with advice and exercises. Background:Head and neck cancer is a growing problem with a 59% increase seen in England between 1995 and 2011. In 2025, almost 12,000 new cases will be diagnosed making it the 6th most common cancer in England. This rise is due to the increase in head and neck cancers related to the human papillomavirus (HPV). Most individuals with HPV-related cancers are otherwise healthy, usually still actively employed, often with young families and generally have a good prognosis. However, difficulty in eating and drinking remains an important concern as it impacts individuals' health and wellbeing, family life, work and personal finances. A dysphagia diagnosis canadd up to 40% to healthcare costs for an inpatient hospital stay, and further costs are associated with long-term management such as tube-feeding. Early intervention might lead to better outcomes than dealing with problems after people have completed all their cancer treatment. This research is a proposal for testing the pre-habilitation intervention described above. Design and method:This research is a pilot study in which a small-scale version of the anticipated large clinical trial will be tested at six NHS hospitals that provide multidisciplinary cancer care. These hospitals will be randomly placed into two groups. Patients newly diagnosed with head and neck cancer who are being treated at the participating hospitals will be approached to take part in this study. Participation will be optional and will not affect cancer treatment. One group will receive the routine 'usual care' which involves meeting with the speech and language therapist (SLT) for general advice and provision of a generic swallowing exercises leaflet. The intervention group will receive the new pre-habilitation package incorporating the components mentioned above. It is not yet known whether this new intervention will make a meaningful difference and therefore it needs to be carefully studied for effectiveness within the NHS context. The SLTs at the intervention hospitals will all receive training in the pre-habilitation package. This pilot study will provide important information about whether hospitals can recruit a sufficient number of patients to the trial, and about whether patients remain in the study long enough to collect all necessary outcome measures. Other factors that may affect results in a large trial will also be explored. This includes whether SLTs deliver the intervention as planned and what patients feel about the intervention and their engagement with it. The information obtained from this pilot study will give funders greater confidence in making future investment to support a large-scale clinical trial of this research. Patient involvement:Patients and the public (PPI) contributed to the initial development of the pre-habilitation intervention, and will continue active participation during this phase. A patient representative will be on the trial steering group to ensure patient interest and safety are paramount and to have input on all patient information produced. The PPI group will also be involved in disseminating findings via social media and at patient conferences. Plain English summaries will be published alongside academic papers.

Research Activity Codes: 7.1 INDIVIDUAL CARE NEEDS
Health Categories: CANCER AND NEOPLASMS