title: The ENHANCES study--Enhancing Head and Neck Cancer patients' Experiences of Survivorship: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Few cancers pose greater challenges than head and neck (H&N) cancer. Residual effects following treatment include body image changes, pain, fatigue and difficulties with appetite, swallowing and speech. Depression is a common comorbidity. There is limited evidence about ways to assist patients to achieve optimal adjustment after completion of treatment. In this study, we aim to examine the effectiveness and feasibility of a model of survivorship care to improve the quality of life of patients who have completed treatment for H&N cancer.
  
  
  METHODS
  This is a preliminary study in which 120 patients will be recruited. A prospective randomised controlled trial of the H&N Cancer Survivor Self-management Care Plan (HNCP) involving pre- and post-intervention assessments will be used. Consecutive patients who have completed a defined treatment protocol for H&N cancer will be recruited from two large cancer services and randomly allocated to one of three study arms: (1) usual care, (2) information in the form of a written resource or (3) the HNCP delivered by an oncology nurse who has participated in manual-based training and skill development in patient self-management support. The trained nurses will meet patients in a face-to-face interview lasting up to 60 minutes to develop an individualised HNCP, based on principles of chronic disease self-management. Participants will be assessed at baseline, 3 and 6 months. The primary outcome measure is quality of life. The secondary outcome measures include mood, self-efficacy and health-care utilisation. The feasibility of implementing this intervention in routine clinical care will be assessed through semistructured interviews with participating nurses, managers and administrators. Interviews with patients who received the HNCP will explore their perceptions of the HNCP, including factors that assisted them in achieving behavioural change.
  
  
  CONCLUSIONS
  In this study, we aim to improve the quality of life of a patient population with unique needs by means of a tailored self-management care plan developed upon completion of treatment. Delivery of the intervention by trained oncology nurses is likely to be acceptable to patients and, if successful, will be a model of care that can be implemented for diverse patient populations.
  
  
  BACKGROUND
  ACTRN12613000542796 (registered on 15 May 2013).
authors.forename: Jane
authors.initials: J
authors.lastname: Turner
authors.affiliation: Institute of Health and Biomedical Innovation, Queensland University of Technology, Musk Ave, Kelvin Grove, QLD 4059, Australia. p.yates@qut.edu.au.
authors.forename: Patsy
authors.initials: P
authors.lastname: Yates
authors.forename: Lizbeth
authors.initials: L
authors.lastname: Kenny
authors.forename: Louisa G
authors.initials: LG
authors.lastname: Gordon
authors.forename: Bryan
authors.initials: B
authors.lastname: Burmeister
authors.forename: Damien
authors.initials: D
authors.lastname: Thomson
authors.forename: Brett
authors.initials: B
authors.lastname: Hughes
authors.forename: Alexandra L
authors.initials: AL
authors.lastname: McCarthy
authors.forename: Chris
authors.initials: C
authors.lastname: Perry
authors.forename: Raymond J
authors.initials: RJ
authors.lastname: Chan
authors.forename: Alana
authors.initials: A
authors.lastname: Fraser
authors.forename: Helen
authors.initials: H
authors.lastname: Skerman
authors.forename: Martin
authors.initials: M
authors.lastname: Batstone
authors.forename: Kathryn
authors.initials: K
authors.lastname: Carswell
mesh_terms: D000223:Adaptation, Psychological; D000339:Affect; D006258:Head and Neck Neoplasms / Q000451:nursing* / Q000523:psychology* / Q000628:therapy; D006801:Humans; D009859:Oncology Nursing / Q000379:methods*; D010174:Pamphlets; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology*; D012107:Research Design; D012648:Self Care / Q000379:methods / Q000523:psychology; D020377:Self Efficacy; D017741:Survivors / Q000523:psychology