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

doi:10.1016/j.jpainsymman.2015.11.026

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

J Pain Symptom Manage. 2016 May;51(5):807-15. doi: 10.1016/j.jpainsymman.2015.11.026. Epub 2016 Feb 12.

Authors

Miriam J Johnson¹, Sara Booth², David C Currow³, Lawrence T Lam⁴, Jane L Phillips⁵

Affiliations

¹ Palliative Medicine, Hull York Medical School, University of Hull, Hull, United Kingdom. Electronic address: miriam.johnson@hyms.ac.uk.
² Department of Oncology, University of Cambridge, Cambridge, United Kingdom.
³ Palliative & Supportive Services, Flinders University, Daw Park, South Australia, Australia.
⁴ Department of Health and Education, The Hong Kong Institute of Education, Hong Kong SAR, China.
⁵ Centre for Cardiovascular and Chronic Care, Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.

PMID: 26880253
DOI: 10.1016/j.jpainsymman.2015.11.026

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 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.

Keywords: Breathlessness; RCT; fan; nonpharmacological; palliative care; semistructured interviews.

Publication types

Clinical Trial, Phase III
Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Anxiety / rehabilitation*
Caregivers / psychology*
Dyspnea / physiopathology
Dyspnea / therapy*
Exercise* / physiology
Feasibility Studies
Female
Humans
Internationality
Interviews as Topic
Male
Patient Education as Topic*
Patient Selection
Qualitative Research
Self-Management*

Associated data

ANZCTR/ACTRN12614000525684