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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
  1. Ben Britton1,
  2. Kristen McCarter2,
  3. Amanda Baker1,
  4. Luke Wolfenden3,
  5. Chris Wratten4,
  6. Judith Bauer5,
  7. Alison Beck1,
  8. Patrick McElduff3,
  9. Sean Halpin2,
  10. Gregory Carter3
  1. 1Faculty of Health and Medicine, Centre for Translational Neuroscience and Mental Health, The University of Newcastle, Callaghan, New South Wales, Australia
  2. 2School of Psychology, The University of Newcastle, Callaghan, New South Wales, Australia
  3. 3School of Medicine & Public Health, The University of Newcastle, Callaghan, New South Wales, Australia
  4. 4Department of Radiation Oncology, Calvary Mater Newcastle Hospital, Waratah, New South Wales, Australia
  5. 5Centre for Dietetics Research, The University of Queensland, St Lucia, Queensland, Australia
  1. Correspondence to Dr Ben Britton; Ben.britton{at}hnehealth.nsw.gov.au

Abstract

Introduction 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 and analysis 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.

Ethics and dissemination Ethics approval from all relevant bodies has been granted. Study findings will be disseminated widely through peer-reviewed publications and conference presentations.

Trial registration number ACTRN12613000320752.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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