| Title: | Phase III pragmatic fast-track single-blinded randomised controlled trial of the Breathlessness Intervention Service (BIS) for intractable breathlessness |
| Principal research question: | (1) Is BIS more effective than standard care for patients with intractable breathlessness from advanced malignant or non-malignant disease? (2) Does it reduce patient and carer distress due to breathlessness, and increase patients’ sense of mastery of the symptom? (3) What are the experiences and views of those who use BIS, their informal carers and the clinicians who refer to it? (4) Is BIS cost-effective? |
| Background: | The Breathlessness Intervention Service (BIS) is a pharmacological and non-pharmacological intervention for patients with intractable breathlessness (regardless of their diagnosis) and their carers. The Pre-Clinical phase consisted of a qualitative study of patients with breathlessness who had a diagnosis of lung cancer or COPD; Phase I was a qualitative study of the first users of the pilot BIS, and Phase II a pilot randomised controlled trial of BIS for patients with chronic obstructive pulmonary disease. Phase III commenced summer 2008 and comprises a definitive trial of BIS for patients with any diagnosis: malignant or non-malignant. |
| Methodology description: | A fast-track, single-blind randomised controlled trial (RCT) of BIS versus standard care for patients with any diagnosis associated with intractable breathlessness, after maximal therapy for the underlying illness. The RCT uses a mixed methods approach employing both quantitative and qualitative methods and economic evaluation of the service. Qualitative capture the experiences of all users (patients, carers and referrers) which shape the service delivery model. They are also essential for exploring the impact of this complex intervention on users’ quality of life; current methods for assessing quality of life in intractable breathlessness are known to be inadequate. |
| Outcome measure description: | Numerical Rating Scale for Distress Due to Breathlessness (primary outcome measure) |
| UK ISRCT Number: | 04119516 |
| Project organisation | |
| Start date: | 1st May 2008 |
| End date: | 30th April 2011 |
| Contact person: | Dr Morag Farquhar |
| Contact Details: | Primary Care Research Unit Institute of Public Health University Forvie Site, Robinson Way Cambridge Cambs CB2 0SR UK Telephone: (01223) 769294 Fax: 01223 762515 E-mail: mcf22@medschl.cam.ac.uk |
| Collaborative: | Dr Sara Booth, Professor Irene Higginson, Toby Prevost, Dr Paul McCroneSee Cambridge University Trust’s Breathlessness Intervention Pages for more details on the service and downloadable leaflets. |
| Funding information | |
| Funding Organisation: | NIHR Research for Patient Benefit |
| Funding Reference: | PB-PG-0107-11134 |
| Funding Amount: | £249,596 |
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| References and Publications | |
| Pre-Clinical phase: Booth S, Silvester S, Todd C (2003). Breathlessness in cancer and chronic obstructive pulmonary disease: using a qualitative approach to describe the experience of patients and carers. Palliative and Supportive Care 1 (4):337-344.Phase I: Booth S, Farquhar M, Gysels M, Bausewein C, Higginson IJ (2006) The impact of a breathlessness intervention service (BIS) on the lives of patients with intractable dyspnoea: a qualitative Phase I study. Journal of Palliative and Supportive Care 4: 287-293. To view the publication click here Phase II: Farquhar M, Higginson IJ, Booth S (2009). Fast-Track Trials in Palliative Care: An Alternative Randomized Controlled Trial Design. Journal of Palliative Medicine 12 (3): 213 Farquhar MC, Higginson IJ, Fagan P, Booth S. Results of a pilot investigation into a complex intervention for breathlessness in advanced chronic obstructive pulmonary disease (COPD): brief report. Palliative and Supportive Care 2009; 8 (2) (in press). Farquhar M, Ewing G, Higginson IJ, Booth S. The experience of using the SEIQoL-DW with patients with advanced chronic obstructive pulmonary disease (COPD): issues of process and outcome. Quality of Life Research 2010;19:619-29 (in press). Other: |
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Phase III pragmatic fast-track single-blinded randomised controlled trial of the Breathlessness Intervention Service (BIS) for intractable breathlessness
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