Is a specialist breathlessness service more effective and cost-effective for patients with advanced cancer and their carers than standard care? Findings of a mixed-method randomised controlled trial.

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Farquhar, Morag C 
Prevost, A Toby 
McCrone, Paul 
Brafman-Price, Barbara 
Bentley, Allison 

BACKGROUND: Breathlessness is common in advanced cancer. The Breathlessness Intervention Service (BIS) is a multi-disciplinary complex intervention theoretically underpinned by a palliative care approach, utilising evidence-based non-pharmacological and pharmacological interventions to support patients with advanced disease. We sought to establish whether BIS was more effective, and cost-effective, for patients with advanced cancer and their carers than standard care. METHODS: A single-centre Phase III fast-track single-blind mixed-method randomised controlled trial (RCT) of BIS versus standard care was conducted. Participants were randomised to one of two groups (randomly permuted blocks). A total of 67 patients referred to BIS were randomised (intervention arm n = 35; control arm n = 32 received BIS after a two-week wait); 54 completed to the key outcome measurement. The primary outcome measure was a 0 to 10 numerical rating scale for patient distress due to breathlessness at two-weeks. Secondary outcomes were evaluated using the Chronic Respiratory Questionnaire, Hospital Anxiety and Depression Scale, Client Services Receipt Inventory, EQ-5D and topic-guided interviews. RESULTS: BIS reduced patient distress due to breathlessness (primary outcome: -1.29; 95% CI -2.57 to -0.005; P = 0.049) significantly more than the control group; 94% of respondents reported a positive impact (51/53). BIS reduced fear and worry, and increased confidence in managing breathlessness. Patients and carers consistently identified specific and repeatable aspects of the BIS model and interventions that helped. How interventions were delivered was important. BIS legitimised breathlessness and increased knowledge whilst making patients and carers feel 'not alone'. BIS had a 66% likelihood of better outcomes in terms of reduced distress due to breathlessness at lower health/social care costs than standard care (81% with informal care costs included). CONCLUSIONS: BIS appears to be more effective and cost-effective in advanced cancer than standard care. TRIAL REGISTRATION: RCT registration at NCT00678405 (May 2008) and Current Controlled Trials ISRCTN04119516 (December 2008).

Adult, Aged, Aged, 80 and over, Anxiety, Caregivers, Cost-Benefit Analysis, Dyspnea, Female, Health Care Costs, Humans, Male, Middle Aged, Neoplasms, Occupational Therapy, Outcome Assessment, Health Care, Palliative Care, Physical Therapy Modalities, Single-Blind Method, Surveys and Questionnaires
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Springer Science and Business Media LLC
Macmillan Cancer Support (unknown)
The study was supported by the following funders: NIHR Research for Patient Benefit (for Phase III RCT funding); Macmillan Cancer Support (MF’s post-doctoral fellowship); The Gatsby Foundation for the initial funding of BIS; and AT Prevost was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London. The study sponsor was CUHNFT.