Fan Activity and Breathlessness (FAB) Study

Brief description of the study: Breathlessness is a devastating symptom of advanced cancer, heart failure, chronic obstructive pulmonary disease and occurs in over 90% of people with lung cancer and 65% of people with heart failure worsening in intensity as death approaches. It is frightening and disabling for both patient and carer. While the mainstay of treatment for breathlessness focuses on a range of pharmacological and there is increasing interest in exploring the use of various non-pharmacological interventions for the management of breathlessness, such as a tailored exercise program, psycho-educational support for patients and carers, and the use of a handheld battery operated fan (‘fan'). Demonstrating whether these self-management strategies can produce incremental benefits to patients is important for building the evidence base for non-pharmacological breathlessness interventions.

Study design: A Phase II multi-site, parallel arm feasibility randomised controlled non-blinded parallel group study comparing the efficacy of a battery operated hand held fan and exercise advice with exercise alone with regard to activity levels in people with intractable breathlessness from any cause. Patients with intractable breathlessness due to cardio-respiratory disease from any cause will be recruited from two UK and two Australian centres.

Aim: To test the feasibility of conducting an adequately powered large, multi-centre, multi-national randomised controlled clinical trial comparing the efficacy of a hand held fan and exercise advice with exercise alone with regard to activity levels in people with optimally treated breathlessness from any cause.

Assessments: The primary assessment is activity levels over 7 days as measured by the activPAL™. This will be measured over the 7 days prior to randomization (Day -8 to 0) and the last 7 days of the study (Days 22-28), with a comparison between arms.

Primary endpoint: Activity levels over 7 days as measured by the activPAL™ monitor.

Fan Activity and Breathlessness (FAB) Study (21kb pdf).