title: A Mixed-Methods, Randomized, Controlled Feasibility Trial to Inform the Design of a Phase III Trial to Test the Effect of the Handheld Fan on Physical Activity and Carer Anxiety in Patients With Refractory Breathlessness.
abstract: The handheld fan is an inexpensive and safe way to provide facial airflow, which may reduce the sensation of chronic refractory breathlessness, a frequently encountered symptom.
  
  
  
  To test the feasibility of developing an adequately powered, multicenter, multinational randomized controlled trial comparing the efficacy of a handheld fan and exercise advice with advice alone in increasing activity in people with chronic refractory breathlessness from a variety of medical conditions, measuring recruitment rates; data quality; and potential primary outcome measures.
  
  
  
  This was a Phase II, multisite, international, parallel, nonblinded, mixed-methods randomized controlled trial. Participants were centrally randomized to fan or control. All received breathlessness self-management/exercise advice and were followed up weekly for four weeks. Participants/carers were invited to participate in a semistructured interview at the study's conclusion.
  
  
  
  Ninety-seven people were screened, 49 randomized (mean age 68 years; 49% men), and 43 completed the study. Site recruitment varied from 0.25 to 3.3/month and screening:randomization from 1.1:1 to 8.5:1. There were few missing data except for the Chronic Obstructive Pulmonary Disease Self-Efficacy Scale (two-thirds of data missing). No harms were observed. Three interview themes included 1) a fan is a helpful self-management strategy, 2) a fan aids recovery, and 3) a symptom control trial was welcome.
  
  
  
  A definitive, multisite trial to study the use of the handheld fan as part of self-management of chronic refractory breathlessness is feasible. Participants found the fan useful. However, the value of information for changing practice or policy is unlikely to justify the expense of such a trial, given perceived benefits, the minimal costs, and an absence of harms demonstrated in this study.
authors.affiliation: Palliative Medicine, Hull York Medical School, University of Hull, Hull, United Kingdom. Electronic address: miriam.johnson@hyms.ac.uk.
authors.forename: Miriam J
authors.initials: MJ
authors.lastname: Johnson
authors.affiliation: Department of Oncology, University of Cambridge, Cambridge, United Kingdom.
authors.forename: Sara
authors.initials: S
authors.lastname: Booth
authors.affiliation: Palliative & Supportive Services, Flinders University, Daw Park, South Australia, Australia.
authors.forename: David C
authors.initials: DC
authors.lastname: Currow
authors.affiliation: Department of Health and Education, The Hong Kong Institute of Education, Hong Kong SAR, China.
authors.forename: Lawrence T
authors.initials: LT
authors.lastname: Lam
authors.affiliation: Centre for Cardiovascular and Chronic Care, Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.
authors.forename: Jane L
authors.initials: JL
authors.lastname: Phillips
mesh_terms: D000368:Aged; D001007:Anxiety / Q000534:rehabilitation*; D017028:Caregivers / Q000523:psychology*; D004417:Dyspnea / Q000503:physiopathology / Q000628:therapy*; D015444:Exercise / Q000502:physiology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D038622:Internationality; D007407:Interviews as Topic; D008297:Male; D010353:Patient Education as Topic; D018579:Patient Selection; D036301:Qualitative Research; D000073278:Self-Management
keywords: Breathlessness; RCT; fan; nonpharmacological; palliative care; semistructured interviews