Eating As Treatment (EAT): A stepped wedge, randomised control trial of a health behaviour change intervention provided by dietitians to improve nutrition in head and neck cancer patients undergoing radiotherapy

The current study is a stepped wedge, randomised controlled trial, whereby each site undergoes a control period (varying in duration from 4 to 16 months) followed by training (consisting of a two day workshop and a one day clinic visit) and then an intervention period (varying in duration from 4 to 16 months). Intervention EAT is a behaviour change counselling intervention based on the strategy delivered by Dr Britton in the pilot study [publication in development]. It has been refined to be delivered by dietitians in the clinical setting, alongside their normal dietetic involvement with HNC patients (i.e. weekly during radiotherapy, fortnightly for six weeks post-radiotherapy and then 'as needed' thereafter). It is largely based on motivational interviewing (MI) and cognitive behavioural therapy (CBT) strategies. EAT is designed to improve health behaviours of HNC patients and maintain their nutrition over the course of their cancer treatment. Of particular interest are behaviours related to sufficient daily nutritional intake, either orally or via feeding tube. Although to a healthy population this may seem a simple task, in order for HNC patients to eat, they must overcome significant barriers of pain, oral disfigurement, mucositis, nausea, reduced or no saliva, taste changes and severe losses of appetite in addition to the premorbid complications of high rates of alcohol misuse, mental illness and poorer self-care. EAT is designed to assist the HNC patient in finding the motivation to eat despite all these barriers, and to provide them with practical behaviour change strategies to support this change. Training will be delivered in a two-day workshop. On the day after training, the trainers will accompany dietitians during their usual consultations to assist with the clinical implementation of EAT. The trainers will return in two months to refresh EAT intervention skills, problem solve clinical concerns and troubleshoot any systems change issues that may have arisen. During the intervention phase, dietitians will participate in at least monthly supervision with one of the trainers (clinical psychologist). Supervision will be used to discuss clinical issues, problem solve and provide skills based feedback. Common themes, barriers and solutions discussed during supervision will be distributed (e.g. email) to participating dietitians. Systems change strategies will be used to encourage the implementation of EAT and, as appropriate, to align dietetic practice with clinical guidelines. This element of the study is aimed at positioning dietetic intervention and counselling as an integral part of cancer care. The following elements will be addressed with staff during training. 1. Due to the prevalence of depression amongst HNC patients, dietitians will be trained in a method used to screen for symptoms of depression (PHQ-2). For patients who are identified to be at risk of depression, dietitians will be encouraged to work with radiation oncologists to implement a referral procedure. This procedure will be site specific and developed in close consultation with hospital staff. Dietitians will be asked to document in client notes when the PHQ-2 is administered and the outcome (i.e. whether the patient was referred to the radiation oncologist). Radiation oncologists will be asked to document in client notes what support option(s) were discussed with the patient and whether a referral was made. 2. Dietitians will be asked to consult with patients in accordance with the schedule documented within the clinical guidelines (weekly during radiotherapy, fortnightly for six weeks post treatment and ‘as required’ thereafter). Dietitians will be asked to document the occurrence of each dietetic consultation within client notes. 3. Sites will be asked to schedule dietetic appointments adjacent to radiotherapy appointments. Integrating dietetics into radiotherapy in this way is designed to position dietetic intervention as an integral part of cancer care for both patients and department staff. 4. To prompt the delivery of dietetic intervention consistent with the intervention/guidelines, the medical records of patients will include a coloured printed prompt, placed by research staff, identifying the patient as a trial participant, outlining the key components of dietetic intervention and the behavioural change techniques recommended for use during the consultation.