A mixed-methods, randomized controlled, feasibility trial to inform the design of a phase 3 trial to test the effect of the hand-held fan on physical activity and carer anxiety in patients with refractory breathlessness

Johnson, Miriam J.; Booth, Sara; Currow, David C.; Lam, Lawrence T.; Phillips, Jane L.

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 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, 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. Results Ninety-seven people were screened, 49 randomized (mean age 68 years; 49% men), and 43 complet ed 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.

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 3 trial to test the effect of the hand-held fan on physical activity and carer anxiety in patients with refractory breathlessness. Journal of pain and symptom management, 51(5), 807-815. https://doi.org/10.1016/j.jpainsymman.2015.11.026

• Journal Article Type: Article
• Acceptance Date: Dec 1, 2015
• Online Publication Date: Feb 12, 2016
• Publication Date: 2016-05
• Deposit Date: Dec 23, 2015
• Publicly Available Date: Nov 23, 2017
• Journal: Journal of pain and symptom management
• Print ISSN: 0885-3924
• Electronic ISSN: 1873-6513
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 51
• Issue: 5
• Pages: 807-815
• DOI: https://doi.org/10.1016/j.jpainsymman.2015.11.026
• Keywords: Refractory breathlessness
• Public URL: https://hull-repository.worktribe.com/output/383440
• Publisher URL: http://www.jpsmjournal.com/article/S0885-3924(16)00052-X/abstract
• Additional Information: Authors' accepted manuscript of article published in: Journal of pain and symptom management, 2016, v.51, issue 5.
• Contract Date: Nov 23, 2017