Title: Development, refinement, and acceptability of an educational intervention for informal carers of patients with breathlessness in advanced disease (Learning about Breathlessness Study 2: LaB2)
Funder: Department of Health and Social Care

Abstract: Background Breathlessness is a distressing and disabling symptom of advanced cancer and non-cancer conditions placing huge burdens on patients and their informal carers (family members and friends who provide complex personal, practical and emotional support). Breathlessness is frightening: carers experience anxiety, isolation, uncertainty, and helplessness, lacking knowledge and confidence in caring tasks and situations which can lead to crises. To address this the Learning about Breathlessness Study programme (LaB) is taking an approach based on the MRC framework for complex interventions and theoretical principles of educational planning to develop and evaluate an educational intervention for carers of patients with breathlessness in advanced disease. LaB1, a mixed method study, included interviews, focus groups and workshops with carers and patients, a clinical expert workshop, and online survey of health care professionals (HCPs). It identified: 1) the need and desire for an intervention among carers 2) six topic areas carers want to learn about in relation to breathlessness 3) topic content for five of the six topics 4) carers preferred intervention delivery modes, and 5) HCP-identified potential evaluation outcomes. It proposed a web-based intervention allowing flexible delivery via four carer-preferred delivery modes: by themselves, with the patient, with others in a group (led by other carers or HCPs) or in one-to-ones with HCPs. Aims Building on LaB1, LaB2 aims to co-develop the educational intervention, investigate its acceptability and deliverability via the four carer-preferred delivery modes and potential outcome measures for a future evaluation (LaB3+). Research Questions (RQs) RQ1) What do informal carers of patients with breathlessness due to advanced disease want to learn about the LaB1 carer-identified Topic 6 (&ldquo;Knowing what to expect in the future&rdquo;) and how can they learn it with a potentially co-present patient, through a web-based educational intervention? RQ2) What should the web-based educational intervention for carers of patients with breathlessness due to advanced disease, informed by carer, patient, health care professional (HCP) and expert views, look like? RQ3) Are all four LaB1-proposed delivery-modes for the web-based intervention acceptable for carers, patients, and HCPs and feasible to deliver in practice? RQ4) Are carer and patient outcome measures, mapped to carer- and clinician-identified outcomes of importance in LaB1, acceptable to carers and patients for a future evaluation of the intervention (LaB3+)? Plan of investigation LaB2 is qualitative MRC framework Phase I work, comprising three tasks. Task 1: establishes topic content with bereaved and current carers relating to Topic 6 (&ldquo;Knowing what to expect in the future&rdquo;), that is sensitive to potentially co-present patients. Task 2: co-develops the prototype web-based intervention, then uses qualitative methods to review and iteratively refine it with carers, patients and HCPs. Task 3: investigates the deliverability and acceptability of the four carer-identified intervention delivery modes from the perspectives of carers, patients and HCPs, and potential outcome measures for a future evaluation (LaB3+). Potential benefit to patients and the NHS Carers needs in advanced disease, and specifically relating to breathlessness, are well-evidenced, yet robustly-developed educational interventions for carers are scarce. An online survey of 365 relevant HCPs endorsed the importance of educating carers about breathlessness through increasing carer confidence and control, helping patients better self-manage breathlessness. HCPs identified improved patient and carer quality of life and carer psychological health, through greater carer coping/problem solving and competence, as potential outcomes of an evidence-based intervention. There was an appetite amongst HCPs for an educational intervention for carers that enabled joint education with patients, giving practical advice and strategies for helping patients. HCPs also identified additional gains for patient and HCP knowledge on managing breathlessness in advanced disease, beyond carer knowledge gains. Resulting impacts may include reduced, costly, crisis events.

Lay abstract: Breathlessness is distressing and disabling. It is common in advanced cancer and non-cancer conditions such as chronic obstructive pulmonary disease. It places burdens on patients and family members/friends who give help and support (informal carers) by providing personal, practical and emotional support, and often overnight vigilance. But many carers lack knowledge and confidence in caring tasks and situations. Breathlessness is frightening: carers experience anxiety, isolation, uncertainty and helplessness. The Learning about Breathlessness Study programme (LaB) aims to develop and test a way of helping carers (an intervention) to learn about breathlessness in life-limiting disease, to increase their knowledge and confidence. Our first study (LaB1) confirmed the need and desire for this help. Working with carers, patients and clinical experts in breathlessness, LaB1 identified six topics carers wanted to learn about, and how, and how we might test whether the intervention works. Carers told us the proposed web-based intervention needed different types of information (pictures, videos and words) from clinical experts and other carers, and be usable in the different ways carers wanted: by themselves, with the patient, with others in a group (led by other carers or by healthcare professionals) or in one-to-one sessions with healthcare professionals. Building on LaB1, this new study (LaB2) works with carers, patients, healthcare professionals and experts in web-based interventions to make a prototype of the intervention. This will include five topics developed in LaB1 and new work on the LaB1-identified sensitive topic &ldquo;Knowing what to expect in the future&rdquo;. We will review and refine the intervention before exploring how it works in practice (deliverability and acceptability). We will ask carers, healthcare professionals and different types of groups to try it out and see what they think of it. We will also start work to prepare for how we test the intervention in future studies.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CANCER AND NEOPLASMS;RESPIRATORY