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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.

Authors

Sara Booth

David C. Currow

Lawrence T. Lam

Jane L. Phillips

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.

Journal Article Type Article
Publication Date 2016-05
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
Institution 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
DOI https://doi.org/10.1016/j.jpainsymman.2015.11.026
Keywords Refractory breathlessness
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.

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