期刊
BMC MEDICINE
卷 12, 期 -, 页码 -出版社
BMC
DOI: 10.1186/s12916-014-0194-2
关键词
Breathlessness; Cancer; Advanced disease; Randomised controlled trial; Complex intervention; Mixed methods
资金
- National Institute for Health Research (NIHR) East of England Primary Care Research Network
- NIHR Research for Patient Benefit (for Phase III RCT funding)
- Macmillan Cancer Support (MF's post-doctoral fellowship
- Gatsby Foundation
- National Institute for Health Research (NIHR) Biomedical Research Centre at Guy's
- St Thomas' NHS Foundation Trust and King's College London
- CUHNFT
- NIHR under its Research for Patient Benefit (RfPB) programme [PB-PG-0107-11134]
- National Institute for Health Research [PB-PG-0107-11134, NF-SI-0611-10209] Funding Source: researchfish
- National Institutes of Health Research (NIHR) [PB-PG-0107-11134] Funding Source: National Institutes of Health Research (NIHR)
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.
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