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

Johnson, MJ; Booth, S; Currow, DC; Lam, LT; Phillips, JL

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

Johnson, MJ Booth, S Currow, DC

Lam, LT

Phillips, JL

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Publication Type:: Journal Article
Citation:: Journal of Pain and Symptom Management, 2016, 51 (5), pp. 807 - 815
Issue Date:: 2016-05-01

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Field	Value	Language
dc.contributor.author	Johnson, MJ	en_US
dc.contributor.author	Booth, S	en_US
dc.contributor.author	Currow, DC https://orcid.org/0000-0003-1988-1250	en_US
dc.contributor.author	Lam, LT https://orcid.org/0000-0001-6183-6854	en_US
dc.contributor.author	Phillips, JL https://orcid.org/0000-0002-3691-8230	en_US
dc.date.available	2020-05-25T19:11:29Z
dc.date.issued	2016-05-01	en_US
dc.identifier.citation	Journal of Pain and Symptom Management, 2016, 51 (5), pp. 807 - 815	en_US
dc.identifier.issn	0885-3924	en_US
dc.identifier.uri	http://hdl.handle.net/10453/41889
dc.description.abstract	© 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved. 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 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.	en_US
dc.relation.ispartof	Journal of Pain and Symptom Management	en_US
dc.relation.isbasedon	10.1016/j.jpainsymman.2015.11.026	en_US
dc.subject.classification	Anesthesiology	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Dyspnea	en_US
dc.subject.mesh	Exercise	en_US
dc.subject.mesh	Feasibility Studies	en_US
dc.subject.mesh	Anxiety	en_US
dc.subject.mesh	Qualitative Research	en_US
dc.subject.mesh	Patient Selection	en_US
dc.subject.mesh	Internationality	en_US
dc.subject.mesh	Aged	en_US
dc.subject.mesh	Caregivers	en_US
dc.subject.mesh	Female	en_US
dc.subject.mesh	Male	en_US
dc.subject.mesh	Interviews as Topic	en_US
dc.subject.mesh	Patient Education as Topic	en_US
dc.subject.mesh	Self-Management	en_US
dc.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	en_US
dc.type	Journal Article
utslib.citation.volume	5	en_US
utslib.citation.volume	51	en_US
utslib.for	1110 Nursing	en_US
utslib.for	11 Medical and Health Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
pubs.organisational-group	/University of Technology Sydney/Strength - CHSP - Health Services and Practice
pubs.organisational-group	/University of Technology Sydney/Strength - CHT - Health Technologies
utslib.copyright.status	open_access
pubs.issue	5	en_US
pubs.publication-status	Published	en_US
pubs.volume	51	en_US

Abstract:

© 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved. 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 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.

Please use this identifier to cite or link to this item:

http://hdl.handle.net/10453/41889