Effectiveness of a breathlessness service for patients suffering from breathlessness in advanced disease: pragmatic fast-track randomized controlled trial

Breathlessness services provide holistic care to patients with advanced disease and their carers and are run by palliative care, respiratory medicine and physiotherapy. To evaluate the effectiveness of the Munich Breathlessness Service (MBS) on patients’ mastery of breathlessness, quality of life, palliative care needs and carer burden and to explore patients’ views on the intervention. Single-blinded randomized controlled fast track trial over a period of 6 weeks; the control group received usual care and started with the MBS after 8 weeks. Primary outcomes: CRQ Mastery, CRQ QoL, Integrated Palliative Care Outcome Scale, Zarit Burden Interview. Intention-to-treat (ITT) analysis using change scores with linear regression adjusting for baseline scores and stratification variables. Follow-up with a self-administered questionnaire. 92/183 patients had immediate and 91 delayed access to the MBS. 17 patients in the intervention group and 5 patients in the control group dropped out before follow-up assessment after 8 weeks (T1). The ITT analyses (n=183) showed significant improvements of CRQ Mastery of 0.367 [95% CI: 0.065; 0.669] and CRQ QoL of 0.226 [95% CI: 0.012; 0.440] score units at T1 in favor of the intervention. No significant improvements in palliative care needs and carer burden. Supplementary and per protocol analyses (n=153) support the ITT analyses. Response rate of questionnaire (89%). Patients stated MBS had a very high (44%) or high (45%) impact on mastery of breathlessness. Physiotherapy input was highly valued by 68%. Breathlessness services are a new and promising way of fostering early integration of palliative care.