A randomised, controlled, feasibility trial of an online, self-guided breathlessness supportive intervention (SELF-BREATHE) for individuals with chronic breathlessness due to advanced disease.

Introduction: SELF-BREATHE is a complex, transdiagnostic, supportive, digital breathlessness intervention co-developed with patients. SELF-BREATHE seeks to build capacity and resilience within health services by improving the lives of people with chronic breathlessness using nonpharmacological, self-management approaches. This study aimed to determine whether SELF-BREATHE is feasible to deliver and acceptable to patients living with chronic breathlessness.
Methods: A parallel, two-arm, single-blind, single-centre, randomised controlled, mixed-methods feasibility trial with participants allocated to 1) intervention group (SELF-BREATHE) or 2) control group (usual National Health Service (NHS) care). The setting was a large multisite NHS foundation trust in south-east London, UK. The participants were patients living with chronic breathlessness due to advanced malignant or nonmalignant disease(s). Participants were randomly allocated (1:1) to an online, self-guided, breathlessness supportive intervention (SELF-BREATHE) and usual care or usual care alone, over 6 weeks. The a priori progression criteria were ≥30% of eligible patients given an information sheet consented to participate; ≥60% of participants logged on and accessed SELF-BREATHE within 2 weeks; and ≥70% of patients reported the methodology and intervention as acceptable.
Results: Between January 2021 and January 2022, 52 (47%) out of 110 eligible patients consented and were randomised. Of those randomised to SELF-BREATHE, 19 (73%) out of 26 logged on and used SELF-BREATHE for a mean±sd (range) 9±8 (1-33) times over 6 weeks. 36 (70%) of the 52 randomised participants completed and returned the end-of-study postal questionnaires. SELF-BREATHE users reported it to be acceptable. Post-intervention qualitative interviews demonstrated that SELF-BREATHE was acceptable and valued by users, improving breathlessness during daily life and at points of breathlessness crisis.
Conclusion: These data support the feasibility of moving to a fully powered, randomised controlled efficacy trial with minor modifications to minimise missing data ( i.e. multiple methods of data collection: face-to-face, telephone, video assessment and by post).
Competing Interests: Conflict of interest: C.C. Reilly received support for the present manuscript from the NIHR; and declares funding received from King's Together and Royal Brompton Hospital – King's Health Partnership Transformation, outside the submitted work. Conflict of interest: M. Maddocks has received grants or contracts from National Institute for Health Research (NIHR) Career Development Fellowship (CDF-2017–10-009) and NIHR Applied Research Collaboration South London (NIHR ARC South London) at King's College Hospital NHS Foundation Trust, outside the submitted work. Conflict of interest: T. Chalder receives salary support from the National Institute for Health Research (NIHR) Mental Health Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London. The views expressed in this article are those of the authors and not necessarily those of the NIHR or the NHS. Conflict of interest: K. Bristowe has received grants or contracts from the National Institute for Health Research, Medical Research Council, Health Education England, European Commission, and Marie Curie, outside the submitted work. Conflict of interest: I.J. Higginson has received grants or contracts from the NIHR, UKRI, Cicely Saunders International and Marie Curie, outside the submitted work.
(Copyright ©The authors 2023.)