title: Eating As Treatment (EAT) study protocol: a stepped-wedge, randomised controlled trial of a health behaviour change intervention provided by dietitians to improve nutrition in patients with head and neck cancer undergoing radiotherapy.
abstract: BACKGROUND
  Maintaining adequate nutrition for Head and Neck Cancer (HNC) patients is challenging due to both the malignancy and the rigours of radiation treatment. As yet, health behaviour interventions designed to maintain or improve nutrition in patients with HNC have not been evaluated. The proposed trial builds on promising pilot data, and evaluates the effectiveness of a dietitian-delivered health behaviour intervention to reduce malnutrition in patients with HNC undergoing radiotherapy: Eating As Treatment (EAT).
  
  
  METHODS
  A stepped-wedge cluster randomised design will be used. All recruitment hospitals begin in the control condition providing treatment as usual. In a randomly generated order, oncology staff at each hospital will receive 2 days of training in EAT before switching to the intervention condition. Training will be supplemented by ongoing supervision, coaching and a 2-month booster training provided by the research team. EAT is based on established behaviour change counselling methods, including motivational interviewing, cognitive-behavioural therapy, and incorporates clinical practice change theory. It 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. EAT will be delivered by dietitians during their usual consultations. 400 patients with HNC (nasopharynx, hypopharynx, oropharynx, oral cavity or larynx), aged 18+, undergoing radiotherapy (>60 Gy) with curative intent, will be recruited from radiotherapy departments at 5 Australian sites. Assessments will be conducted at 4 time points (first and final week of radiotherapy, 4 and 12 weeks postradiotherapy). The primary outcome will be a nutritional status assessment.
  
  
  BACKGROUND
  Ethics approval from all relevant bodies has been granted. Study findings will be disseminated widely through peer-reviewed publications and conference presentations.
  
  
  BACKGROUND
  ACTRN12613000320752.
authors.affiliation: Faculty of Health and Medicine, Centre for Translational Neuroscience and Mental Health, The University of Newcastle, Callaghan, New South Wales, Australia.
authors.forename: Ben
authors.initials: B
authors.lastname: Britton
authors.affiliation: School of Psychology, The University of Newcastle, Callaghan, New South Wales, Australia.
authors.forename: Kristen
authors.initials: K
authors.lastname: McCarter
authors.affiliation: Faculty of Health and Medicine, Centre for Translational Neuroscience and Mental Health, The University of Newcastle, Callaghan, New South Wales, Australia.
authors.forename: Amanda
authors.initials: A
authors.lastname: Baker
authors.affiliation: School of Medicine & Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.
authors.forename: Luke
authors.identifier: http://orcid.org/0000-0002-6178-3868
authors.initials: L
authors.lastname: Wolfenden
authors.affiliation: Department of Radiation Oncology, Calvary Mater Newcastle Hospital, Waratah, New South Wales, Australia.
authors.forename: Chris
authors.initials: C
authors.lastname: Wratten
authors.affiliation: Centre for Dietetics Research, The University of Queensland, St Lucia, Queensland, Australia.
authors.forename: Judith
authors.initials: J
authors.lastname: Bauer
authors.affiliation: Faculty of Health and Medicine, Centre for Translational Neuroscience and Mental Health, The University of Newcastle, Callaghan, New South Wales, Australia.
authors.forename: Alison
authors.initials: A
authors.lastname: Beck
authors.affiliation: School of Medicine & Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.
authors.forename: Patrick
authors.initials: P
authors.lastname: McElduff
authors.affiliation: School of Psychology, The University of Newcastle, Callaghan, New South Wales, Australia.
authors.forename: Sean
authors.initials: S
authors.lastname: Halpin
authors.affiliation: School of Medicine & Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.
authors.forename: Gregory
authors.initials: G
authors.lastname: Carter
mesh_terms: D015928:Cognitive Behavioral Therapy; D003863:Depression / Q000209:etiology; D004435:Eating; D015438:Health Behavior; D006801:Humans; D044342:Malnutrition / Q000517:prevention & control*; D062405:Motivational Interviewing; D009752:Nutritional Status; D064686:Nutritionists / Q000193:education; D010039:Otorhinolaryngologic Neoplasms / Q000523:psychology / Q000532:radiotherapy*; D011788:Quality of Life; D012107:Research Design