EAT: A stepped wedge cluster randomised trial to improve nutrition in head and neck cancer patients undergoing radiotherapy — ASN Events
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EAT: A stepped wedge cluster randomised trial to improve nutrition in head and neck cancer patients undergoing radiotherapy (#522)

Ben Britton 1 2 , Amanda Baker 3 , Judith Bauer 4 , Luke Wolfenden 5 , Chris Wratten 5 6 , Alison Beck 3 , Patrick McElduff 7 , Gregory Carter 2 5
  1. Priority Research Centre for Translational Neuroscience and Mental Health, University of Newcastle, Newcastle, NSW, Australia
  2. Psycho-Oncology Service, Calvary Mater Newcastle, Newcastle, NSW, Australia
  3. Priority Research Centre for Translational Neuroscience and Mental Health, University of Newcastle, Newcastle, NSW, Australia
  4. University of Queensland, Brisbane, QLD, Australia
  5. University of Newcastle, Newcastle, NSW, Australia
  6. Department Radiation Oncology, Calvary Mater Newcastle, Newcastle, NSW, Australia
  7. Clinical Trials Unit Hunter Medical Research Institute, University of Newcastle, Newcastle, NSW, Australia

Background: Maintenance of adequate nutrition in Head and Neck Cancer
(HNC) patients is challenging. The rigours of radiation treatment and the burden of the malignancy make it difficult to maintain sufficient nutrition. However, health behaviour interventions designed to improve nutrition in HNC patients have not yet been evaluated.

Aims: The proposed trial builds on promising pilot data and evaluates the effectiveness of a dietitian delivered health behaviour intervention: Eating As Treatment (EAT) to reduce malnutrition in HNC patients undergoing radiotherapy.

Research Design: A stepped wedge cluster randomised design will be used.
Each site will begin the study as a control hospital providing treatment as usual. Each site will receive two days of EAT training in a randomly generated order and begin contributing to the intervention arm of the study.

Intervention: EAT is based on established behaviour change counselling methods, including motivational interviewing (MI), cognitive behaviour therapy (CBT) and systems change theory. EAT is designed to improve motivation to eat despite a range of barriers (pain, mucositis, nausea, reduced or no saliva, taste changes and appetite loss), and to provide patients with practical behaviour change strategies. The EAT intervention will be delivered by dietitians alongside their normal consultations.

Methods: 400 HNC patients, aged 18+ will be recruited from radiotherapy departments in five Australian sites. Assessments will be conducted at five time points by project officers blinded to the intervention allocation. Assessments include a nutrition assessment and self report depression screen. Treatment interruption and completion, number and length of hospital stays and dietetic contacts will be retrieved from medical records. Covariates will be documented, including mucositis; dysphagia; primary tumour site; stage; concurrent chemotherapy; surgical procedure, proposed radiotherapy dose; fractionation and overall treatment time; gender; age; live-in carer; smoking; alcohol consumption; and presence of a feeding tube.