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

Miriam Jane JOHNSON, Sara BOOTH, David Christopher CURROW, Lawrence Tak-Ming LAM, Jane Louise PHILLIPS

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Context: 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. Objectives: To test the feasibility of developing an adequately powered, multicenter, multinational randomized controlled trial (RCT) 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. Methods: This was a phase II, multisite, international, parallel, non-blinded, mixed-methods RCT. 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 semi-structured interview at the study’s conclusion. Results: 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. Conclusion: 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. Copyright © 2016 American Academy of Hospice and Palliative Medicine.
Original languageEnglish
Pages (from-to)807-815
JournalJournal of Pain and Symptom Management
Volume51
Issue number5
Early online dateFeb 2016
DOIs
Publication statusPublished - May 2016

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Dyspnea
Caregivers
Anxiety
Self Care
Randomized Controlled Trials
Exercise
Interviews
Self Efficacy
Random Allocation
Chronic Obstructive Pulmonary Disease
Cost-Benefit Analysis
Outcome Assessment (Health Care)

Citation

Johnson, M. J., Booth, S., Currow, D. C., Lam, L. T., & Phillips, J. L. (2016). 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, Journal of Pain and Symptom Management, 51(5), 807-815.

Keywords

  • Breathlessness
  • Fan
  • Non-pharmacological
  • RCT
  • Palliative care
  • Semi-structured interviews