title: Protocol for the CHEST Australia Trial: a phase II randomised controlled trial of an intervention to reduce time-to-consult with symptoms of lung cancer.
abstract: BACKGROUND
  Lung cancer is the most common cancer worldwide, with 1.3 million new cases diagnosed every year. It has one of the lowest survival outcomes of any cancer because over two-thirds of patients are diagnosed when curative treatment is not possible. International research has focused on screening and community interventions to promote earlier presentation to a healthcare provider to improve early lung cancer detection. This paper describes the protocol for a phase II, multisite, randomised controlled trial, for patients at increased risk of lung cancer in the primary care setting, to facilitate early presentation with symptoms of lung cancer.
  
  
  METHODS
  The intervention is based on a previous Scottish CHEST Trial that comprised of a primary-care nurse consultation to discuss and implement a self-help manual, followed by self-monitoring reminders to improve symptom appraisal and encourage help-seeking in patients at increased risk of lung cancer. We aim to recruit 550 patients from two Australian states: Western Australia and Victoria. Patients will be randomised to the Intervention (a health consultation involving a self-help manual, monthly prompts and spirometry) or Control (spirometry followed by usual care). Eligible participants are long-term smokers with at least 20 pack years, aged 55 and over, including ex-smokers if their cessation date was less than 15 years ago. The primary outcome is consultation rate for respiratory symptoms.
  
  
  BACKGROUND
  Ethical approval has been obtained from The University of Western Australia's Human Research Ethics Committee (RA/4/1/6018) and The University of Melbourne Human Research Committee (1 441 433). A summary of the results will be disseminated to participants and we plan to publish the main trial outcomes in a single paper. Further publications are anticipated after further data analysis. Findings will be presented at national and international conferences from late 2016.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trial Registry ACTRN 1261300039 3752.
authors.affiliation: Department of General Practice, School of Primary, Aboriginal and Rural Health Care, The University of Western Australia, Crawley, Western Australia, Australia.
authors.forename: Sonya R
authors.initials: SR
authors.lastname: Murray
authors.affiliation: The Centre of Academic Primary Care, The University of Aberdeen, Aberdeen, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Murchie
authors.affiliation: The Centre of Academic Primary Care, The University of Aberdeen, Aberdeen, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: Campbell
authors.affiliation: Department of General Practice, School of Primary, Aboriginal and Rural Health Care, The University of Western Australia, Crawley, Western Australia, Australia Department of General Practice, University of Melbourne, Melbourne, Victoria, Australia The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
authors.forename: Fiona M
authors.initials: FM
authors.lastname: Walter
authors.affiliation: Department of General Practice, Monash University, Melbourne, Victoria, Australia.
authors.forename: Danielle
authors.initials: D
authors.lastname: Mazza
authors.affiliation: Department of General Practice, University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Emily
authors.initials: E
authors.lastname: Habgood
authors.affiliation: Department of General Practice, School of Primary, Aboriginal and Rural Health Care, The University of Western Australia, Crawley, Western Australia, Australia.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Kutzer
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Martin
authors.affiliation: Centre for Health Economics Research and Evaluation (CHERE), University of Technology, Sydney, New South Wales, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Goodall
authors.affiliation: Royal Prince Alfred Hospital, Sydney, New South Wales, Australia Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: David J
authors.initials: DJ
authors.lastname: Barnes
authors.affiliation: Department of General Practice, School of Primary, Aboriginal and Rural Health Care, The University of Western Australia, Crawley, Western Australia, Australia Department of General Practice, University of Melbourne, Melbourne, Victoria, Australia The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
authors.forename: Jon D
authors.identifier: http://orcid.org/0000-0002-5274-6336
authors.initials: JD
authors.lastname: Emery
mesh_terms: D000368:Aged; D001315:Australia; D059026:Diagnostic Self Evaluation; D055088:Early Detection of Cancer; D005260:Female; D015438:Health Behavior; D006801:Humans; D008175:Lung Neoplasms / Q000150:complications / Q000175:diagnosis* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009726:Nurses; D010342:Patient Acceptance of Health Care; D011320:Primary Health Care; D012017:Referral and Consultation; D012107:Research Design; D012648:Self Care; D012907:Smoking / Q000009:adverse effects*; D013147:Spirometry; D013909:Thorax
keywords: ONCOLOGY; PREVENTIVE MEDICINE; PRIMARY CARE; PUBLIC HEALTH