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

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 (RCT) 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, non-blinded, mixed-methods RCT. 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 semi-structured 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. Copyright © 2016 American Academy of Hospice and Palliative Medicine.