Title: A self-guided, internet-based intervention for patients with chronic breathlessness (SELF - BREATHE)
Funder: Health Education England

Abstract: Rationale In the UK 2 million people suffer from breathlessness as a result of cancer, chronic respiratory or heart disease. Breathlessness is a challenging clinical problem, for many patients their breathlessness becomes chronic i.e. persistent despite optimal pharmacological treatment of the underlying disease. Chronic breathlessness is associated with physical disability, high health care cost and distress. Breathlessness support services have demonstrated significant improvements in patient's ability to control their breathlessness and are cost effective. Unfortunately, accesses to such services are not available within the NHS, and implementation will have significant cost implications despite their effectiveness. Therefore, an alternative mode of providing patients access to breathlessness supportive interventions at scale and minimal cost is needed. Aim To develop and test the feasibility of a self-guided, internet-based intervention for patients with chronic breathlessness (SELF-BREATHE). Overview methods The methodology builds on the Medical Research Council (MRC) guidance for the development and evaluation of a complex intervention, MORECARE statement, and IDEAS (Integrate, DEsign, Assess and Share) framework for the development of digital behaviour change interventions. This study has two parts. Detailed methodology 1. Development of SELF - BREATHE Aim: To develop a self-guided, internet-based intervention (SELF -h; BREATHE) for patients with chronic breathlessness. Design: Development of SELF -h; BREATHE will be an iterative process between: the research team, clinicians, patients and digital health experts (HARK2). Development methodology will include: literature scoping, qualitative interviews with patients (n=20), transparent expert consultation. 2. Feasibility Testing Aim: To determine the feasibility of carrying out an RCT of the effectiveness of SELF-BREATHE as an intervention, method of evaluation and understand user's experiences and perceived value of SELF-BREATHE. Design: A single blind randomised controlled feasibility trial (RCT) comprising two groups: 1) intervention (SELF-BREATHE in addition to standard care); 2) control group (standard care). Population: 40 patients with malignant and non-malignant disease and chronic breathlessness, who have access to the internet. Intervention (to be refined): SELF -h; BREATHE builds on Leventhal's common-sense model of self-regulation; to change patients negative health beliefs and behaviours through education and the establishment of positive coping strategies to improve their self-efficacy with regards to breathlessness management. SELF -h; BREATHE has two core modules focused on 1) acute and 2) chronic breathlessness management, underpinned by breathlessness interventions e.g. breathing control, fan therapy, exercise. SELF - BREATHE will be delivered via a secure and password- protected website, which patients can access via computer, tablet or smart phone.Control: Standard NHS care as was available to patients prior to entry into the trial. Feasibility outcomes: Rates of referral, percentage eligible, dropout rates, numbers completing and explanatory qualitative interviews to assess the acceptability of the intervention (n=15). Patient reported outcomes: Distress due to breathlessness measured on the numerical rating scale; Dysponea 12; The Brief Illness Perception Questionnaire; Self-efficacy for managing breathlessness. Health economics: The Client Service Receipt Inventory and cost mapping. A priori progression criteria to a full RCT: 50% consent rate; 65% completion rate at 6 weeks, 75% of participants finding the methodology and intervention acceptable.

Lay abstract: Background Over 2 million people experience symptomatic breathlessness in the UK every year. Breathlessness is common in cancer, lung and heart disease. Unfortunately, for many people despite the best medical management of their disease, their breathlessness persists. This type of breathlessness is called chronic breathlessness. Chronic breathlessness leads to a decline in a patient's activity levels, an increase dependence on others for help, as well as feelings of isolation. Chronic breathlessness often leaves patients and those close to them feeling worried and helpless. People with chronic breathlessness can have sudden and unexpected increases in their breathlessness, called 'breathlessness attacks'. These breathlessness attacks can be very frightening, and many people seek help during an attack via emergency services. Recent data suggests that 1/3 of attendances to UK Emergency Department because of breathlessness attacks could be avoided if patients had access to breathlessness self - management plans or support at home. Breathlessness support services for patients with chronic breathlessness have been shown to improve patients' self-management and reduce their distress. However, no such services are currently provided by the NHS due to high funding and staffing requirements. In this study we seek to answer two questions: a) could there be a quicker and cheaper way for patients to access this treatment? b) could breathlessness supported services be offered online? Aim There are two main parts to the proposed study: I. The development of an internet based self-guided treatment of chronic breathlessness (called SELF - BREATHE) II. Testing SELF -h; BREATHE in a randomised controlled trial i.e. SELF- BREATHE in addition to NHS health care vs NHS health care alone Methods I. Development The content of SELF-BREATHE builds on proven breathlessness support services, and is developed in partnership with: patients, breathlessness experts, internet experts. The development will take a year and will include: interviews with patients with chronic breathlessness and monthly development meetings. II. Testing Forty patients with chronic breathlessness who agree to take part in the study will be assigned at random (by chance) to either use SELF- BREATHE plus NHS health care or to usual NHS health care alone. The study will measure: how many patients took part, how many patients completed the SELF -h; BREATHE programme, and how often they access the website. Patients will be asked about their good and bad experiences of using SELF -h; BREATHE. Patients in the usual care group will be asked about their experience of the study design e.g. the randomisation process. Importance of study results This project will provide important information as to whether SELF -h; BREATHE should be tested further in a larger study to see if compared to normal health care SELF-BREATHE helps patients to manage their breathlessness better (clinical effectiveness) and to reduce hospital attendances (cost effectiveness). Patient and Public Involvement (PPI) PPI is central to this study. The study idea was generated from a breathlessness PPI event. PPI comments have shaped this proposal. PPI will help in the development and testing of SELF -h; BREATHE. The PPI strategy for this project will include input into revising patient information sheets, and dissemination of the finding e.g. writing of research summaries, development of infographic and supporting grant applications to further test SELF- BREATHE if needed.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: RESPIRATORY