title: Evaluating holistic needs assessment in outpatient cancer care--a randomised controlled trial: the study protocol.
abstract: BACKGROUND
  People living with and beyond cancer are vulnerable to a number of physical, functional and psychological issues. Undertaking a holistic needs assessment (HNA) is one way to support a structured discussion of patients' needs within a clinical consultation. However, there is little evidence on how HNA impacts on the dynamics of the clinical consultation. This study aims to establish (1) how HNA affects the type of conversation that goes on during a clinical consultation and (2) how these putative changes impact on shared decision-making and self-efficacy.
  
  
  METHODS
  The study is hosted by 10 outpatient oncology clinics in the West of Scotland and South West England. Participants are patients with a diagnosis of head and neck, breast, urological, gynaecological and colorectal cancer who have received treatment for their cancer. Patients are randomised to an intervention or control group. The control group entails standard care--routine consultation between the patient and clinician. In the intervention group, the patient completes a holistic needs assessment prior to consultation. The completed assessment is then given to the clinician where it informs a discussion based on the patient's needs and concerns as identified by them. The primary outcome measure is patient participation, as determined by dialogue ratio (DR) and preponderance of initiative (PI) within the consultation. The secondary outcome measures are shared decision-making and self-efficacy. It is hypothesised that HNA will be associated with greater patient participation within the consultation, and that shared decision-making and feelings of self-efficacy will increase as a function of the intervention.
  
  
  BACKGROUND
  This study has been given a favourable opinion by the West of Scotland Research Ethics Committee and NHS Research & Development. Study findings will be disseminated through peer-reviewed publications and conference attendance.
  
  
  BACKGROUND
  Clinical Trials.gov NCT02274701.
authors.affiliation: University of the West of Scotland, Ayr, UK.
authors.forename: Austyn
authors.initials: A
authors.lastname: Snowden
authors.affiliation: Department of Mental Health, University of the West of Scotland, Paisley, UK.
authors.forename: Jenny
authors.initials: J
authors.lastname: Young
authors.affiliation: Quality Unit, Department of Health and Social Care, Scottish Government, Edinburgh, UK.
authors.forename: Craig
authors.initials: C
authors.lastname: White
authors.affiliation: Ayrshire Central Hospital, Irvine, UK.
authors.forename: Esther
authors.initials: E
authors.lastname: Murray
authors.affiliation: The Université du Québec à Montréal, Montréal, Canada.
authors.forename: Claude
authors.initials: C
authors.lastname: Richard
authors.affiliation: The Université du Québec à Montréal, Montréal, Canada.
authors.forename: Marie-Therese
authors.initials: MT
authors.lastname: Lussier
authors.affiliation: Department of Statistics, University of the West of Scotland, Paisley, UK.
authors.forename: Ewan
authors.initials: E
authors.lastname: MacArthur
authors.affiliation: Department of Colorectal, The Beatson West of Scotland Cancer Centre, Glasgow, UK.
authors.forename: Dawn
authors.initials: D
authors.lastname: Storey
authors.affiliation: Department of Head and Neck, The Beatson West of Scotland Cancer Centre, Glasgow, UK.
authors.forename: Stefano
authors.initials: S
authors.lastname: Schipani
authors.affiliation: Department of Oncology, Royal Cornwall Hospital, Truro, UK.
authors.forename: Duncan
authors.initials: D
authors.lastname: Wheatley
authors.affiliation: Department of Oncology, The Southern General Hospital, Glasgow, UK.
authors.forename: Jeremy
authors.initials: J
authors.lastname: McMahon
authors.affiliation: Department of Oncology, The Southern General Hospital, Glasgow, UK.
authors.forename: Elaine
authors.initials: E
authors.lastname: Ross
mesh_terms: D000553:Ambulatory Care / Q000379:methods*; D002985:Clinical Protocols; D003657:Decision Making; D004739:England / Q000453:epidemiology; D005260:Female; D006694:Holistic Health; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000523:psychology / Q000628:therapy*; D010045:Outpatients / Q000523:psychology / Q000706:statistics & numerical data*; D010166:Palliative Care / Q000379:methods*; D010865:Pilot Projects; D012606:Scotland / Q000453:epidemiology; D012648:Self Care
keywords: MEDICAL EDUCATION & TRAINING; MENTAL HEALTH; ONCOLOGY; SOCIAL MEDICINE; STATISTICS & RESEARCH METHODS