title: Management of the respiratory distress symptom cluster in lung cancer: a randomised controlled feasibility trial.
abstract: BACKGROUND
  Breathlessness, cough and fatigue are distressing symptoms for patients with lung cancer. There is evidence that these three symptoms form a discreet symptom cluster. This study aimed to feasibly test a new non-pharmacological intervention for the management of the Respiratory Distress Symptom Cluster (breathlessness-cough-fatigue) in lung cancer.
  
  
  METHODS
  This was a multi-centre, randomised controlled non-blinded parallel group feasibility trial. Eligible patients (patients with primary lung cancer and 'bothered' by at least two of the three cluster symptoms) received usual care plus a multicomponent intervention delivered over two intervention training sessions and a follow-up telephone call or usual care only. Follow-up was for 12 weeks, and end-points included six numerical rating scales for breathlessness severity, Dyspnoea-12, Manchester Cough in Lung Cancer scale, FACIT-Fatigue scale, Hospital Anxiety and Depression scale, Lung Cancer Symptom Scale and the EQ-5D-3L, collected at baseline, week 4 and week 12.
  
  
  RESULTS
  One hundred seven patients were randomised over 8 months; however, six were removed from further analysis due to protocol violations (intervention group n = 50 and control group n = 51). Of the ineligible patients (n = 608), 29 % reported either not experiencing two or more symptoms or not being 'bothered' by at least two symptoms. There was 29 % drop-out by week 4, and by week 12, a further two patients in the control group were lost to follow-up. A sample size calculation indicated that 122 patients per arm would be needed to detect a clinically important difference in the main outcome for breathlessness, cough and fatigue.
  
  
  CONCLUSIONS
  The study has provided evidence of the feasibility and acceptability of a new intervention in the lung cancer population and warrants a fully powered trial before we reach any conclusions. The follow-on trial will test the hypothesis that the intervention improves symptom cluster of breathlessness, cough and fatigue better than usual care alone. Full economic evaluation will be conducted in the main trial.
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.|The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: Janelle
authors.initials: J
authors.lastname: Yorke
authors.affiliation: Health Services Research, University of Liverpool, Liverpool, UK.
authors.forename: Mari
authors.initials: M
authors.lastname: Lloyd-Williams
authors.affiliation: Centre for Respiratory and Allergy, University Hospital South Manchester, Manchester, UK.|Faculty of Medicine and Human Sciences, University of Manchester, Manchester, UK.
authors.forename: Jacky
authors.initials: J
authors.lastname: Smith
authors.affiliation: The Christie NHS Foundation Trust, Manchester, UK.|Faculty of Medicine and Human Sciences, University of Manchester, Manchester, UK.
authors.forename: Fiona
authors.initials: F
authors.lastname: Blackhall
authors.affiliation: The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: Amelie
authors.initials: A
authors.lastname: Harle
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.
authors.forename: June
authors.initials: J
authors.lastname: Warden
authors.affiliation: Health Services Research, University of Liverpool, Liverpool, UK.
authors.forename: Jackie
authors.initials: J
authors.lastname: Ellis
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Pilling
authors.affiliation: Airways Clinic Services, Lancashire Teaching Hospitals Foundation Trust, Lancashire, UK.
authors.forename: Jemma
authors.initials: J
authors.lastname: Haines
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.
authors.forename: Karen
authors.initials: K
authors.lastname: Luker
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK. alex.molasiotis@polyu.edu.hk.|School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong, China. alex.molasiotis@polyu.edu.hk.
authors.forename: Alex
authors.initials: A
authors.lastname: Molassiotis
mesh_terms: D019050:Acupressure / Q000379:methods; D000368:Aged; D001945:Breathing Exercises / Q000379:methods; D003371:Cough / Q000209:etiology / Q000628:therapy*; D004417:Dyspnea / Q000209:etiology / Q000628:therapy*; D005221:Fatigue / Q000209:etiology / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000150:complications*; D008297:Male; D010353:Patient Education as Topic; D013577:Syndrome
keywords: Breathlessness; Cough; Dyspnoea; Fatigue; Lung cancer; Non-pharmacological intervention; Respiratory symptoms; Self-management; Symptom cluster; Symptoms