• Flavia Swan, Anne English, Victoria Allgar, Simon P Hart, and Miriam J Johnson.
• Wolfson Palliative Care Research Centre, Allam Medical Building, Hull York Medical School (HYMS), University of Hull, Hull, UK. Electronic address: flavia.swan@hyms.ac.uk.
• J Pain Symptom Manage. 2019 Jun 1; 57 (6): 1051-1061.e1.

ContextThe battery-operated hand-held fan ("fan") and the Calming Hand (CH), a cognitive strategy, are interventions used in clinical practice to relieve chronic breathlessness.ObjectiveTo test the feasibility of a Phase III randomized controlled trial (RCT) evaluating the impact of the fan and/or CH compared with exercise advice alone for the relief of chronic breathlessness due to respiratory conditions.MethodsA single-site, feasibility "2 × 2" factorial, nonblinded, mixed-methods RCT was performed. Participants randomly allocated to four groups: fan + exercise advice, CH + exercise advice, fan + CH + exercise advice, and exercise advice alone. Measures included recruitment, acceptability, data quality and study outcomes (baseline and day 28), modified Incremental Shuttle Walk Test (mISWT), recovery time from exertion-induced breathlessness, life-space questionnaire, General Self-Efficacy Scale, and breathlessness numerical rating scales. Willing participants and carers were interviewed at study end.ResultsRecruitment/acceptability/data completion: 53 people were screened, 40 randomized and completed (mean age 72 years (SD 9.8), 70% male). There were few missing data (mISWT, n = 2). Recovery time (seconds) from exertion-induced breathlessness showed most improvement for the fan; mean reduction from baseline -33.5 vs. CH mean increase from baseline 5.7. This represents a recovery speed at day 28 (-20.4%) faster for the fan vs. 4.1% slower for the CH. Qualitative data indicated participants valued the faster recovery and identified the fan as a useful "medical" device but found the CH unhelpful.ConclusionA Phase III RCT is feasible. Mixed-methods data synthesis supports recovery time as a novel, meaningful outcome measure.Crown Copyright © 2019. Published by Elsevier Inc. All rights reserved.

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