Study protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease

Morag C Farquhar, A Toby Prevost, Paul McCrone, Irene J Higginson, Jennifer Gray, Barbara Brafman-Kennedy, Sara Booth, Morag C Farquhar, A Toby Prevost, Paul McCrone, Irene J Higginson, Jennifer Gray, Barbara Brafman-Kennedy, Sara Booth

Abstract

Background: Breathlessness in advanced disease causes significant distress to patients and carers and presents management challenges to health care professionals. The Breathlessness Intervention Service (BIS) seeks to improve the care of breathless patients with advanced disease (regardless of cause) through the use of evidence-based practice and working with other healthcare providers. BIS delivers a complex intervention (of non-pharmacological and pharmacological treatments) via a multi-professional team. BIS is being continuously developed and its impact evaluated using the MRC's framework for complex interventions (PreClinical, Phase I and Phase II completed). This paper presents the protocol for Phase III.

Methods/design: Phase III comprises a pragmatic, fast-track, single-blind randomised controlled trial of BIS versus standard care. Due to differing disease trajectories, the service uses two broad service models: one for patients with malignant disease (intervention delivered over two weeks) and one for patients with non-malignant disease (intervention delivered over four weeks). The Phase III trial therefore consists of two sub-protocols: one for patients with malignant conditions (four week protocol) and one for patients with non-malignant conditions (eight week protocol). Mixed method interviews are conducted with patients and their lay carers at three to five measurement points depending on randomisation and sub-protocol. Qualitative interviews are conducted with referring and non-referring health care professionals (malignant disease protocol only). The primary outcome measure is 'patient distress due to breathlessness' measured on a numerical rating scale (0-10). The trial includes economic evaluation. Analysis will be on an intention to treat basis.

Discussion: This is the first evaluation of a breathlessness intervention for advanced disease to have followed the MRC framework and one of the first palliative care trials to use fast track methodology and single-blinding. The results will provide evidence of the clinical and cost-effectiveness of the service, informing its longer term development and implementation of the model in other centres nationally and internationally. It adds to methodological developments in palliative care research where complex interventions are common but evidence sparse.

Trial registration: ClinicalTrials.gov: NCT00678405ISRCTN: ISRCTN04119516.

Figures

Figure 1
Figure 1
BIS Phase III measurement point flow chart for non-malignant conditions. shaded area = intervention
Figure 2
Figure 2
BIS Phase III measurement point flow chart - malignant conditions. shaded area = intervention

References

    1. Higginson I, McCarthy M. Measuring symptoms in terminal cancer: are pain and dyspnoea controlled? J R Soc Med. 1989;82:264–7.
    1. Skevington M, Pilaar M, Routh D. et al.On the language of breathlessness. Psychol Health. 1997;12:677–89. doi: 10.1080/08870449708407414.
    1. Booth S, Silvester S, Todd C. Breathlessness in cancer and chronic obstructive pulmonary disease: using a qualitative approach to describe the experience of patients and carers. Palliat Support Care. 2003;1(4):337–44.
    1. Dudgeon D, Christiansen L, Sloan J, Lertzman M, Clement K. Dyspnoea in cancer patients: prevalence and associated factors. J Pain Symptom Manage. 2001;21(2):95–102. doi: 10.1016/S0885-3924(00)00258-X.
    1. Muers MF, Round CE. Palliation of symptoms in non-small cell lung cancer: a study by the Yorkshire Regional Cancer Organisation Thoracic Group. Thorax. 1993;48:339–43. doi: 10.1136/thx.48.4.339.
    1. Health and Safety Laboratory. Projection of mesothelioma mortality in Great Britain (RR 728) London: Health and Safety Executive; 2009.
    1. Edmonds P, Karlsen S. A comparison of the palliative care needs of patients dying from chronic respiratory diseases and lung cancer. Palliat Med. 2001;15:287–95. doi: 10.1191/026921601678320278.
    1. Hopwood P, Stephens R. Symptoms at presentation for treatment in patients with lung cancer. Implications for the evaluation of palliative treatment. Br J Cancer. 1995;71:633–6. doi: 10.1038/bjc.1995.124.
    1. Booth S, Moosavi SH, Higginson IJ. The etiology and management of intractable breathlessness in patients with advanced cancer: a systematic review of pharmacological therapy. Nat Clin Pract Oncol. 2008;5(2):90–100. doi: 10.1038/ncponc1034.
    1. Booth S, Farquhar M, Gysels M, Bausewein C, Higginson IJ. The impact of a breathlessness intervention service (BIS) on the lives of patients with intractable dyspnoea: a qualitative Phase I study. Palliat Support Care. 2006;4:287–93.
    1. Seamark DA, Blake SD, Seamark CJ, Halpin DM. Living with severe chronic obstructive pulmonary disease (COPD): perceptions of patients and their carers. An interpretative phenomenological analysis. Palliat Med. 2004;18(7):619–25. doi: 10.1191/0269216304pm928oa.
    1. NCCCC. National guidelines on management of chronic obstructive pulmonary disease in adults in primary and secondary care. Thorax. 2004;59(Suppl 1):1–232.
    1. Goldberg R, Hillberg R, Reinecker L, Goldstein R. Evaluation of patients with severe pulmonary disease before and after pulmonary rehabilitation. Disabil Rehabil. 2004;26(11):641–8. doi: 10.1080/09638280410001663120.
    1. Man WDC, Polkey MI, Donaldson N, Gray BJ, Moxham J. Community pulmonary rehabilitation after hospitalisation for acute exacerbations of chronic obstructive pulmonary disease: randomised controlled study. BMJ. 2004;329:1209–13. doi: 10.1136/bmj.38258.662720.3A.
    1. Corner J, Plant H, A'Hern R. et al.Non-pharmacological intervention for breathlessness in lung cancer. Palliat Med. 1996;10:299–305. doi: 10.1177/026921639601000405.
    1. Bredin M, Corner J, Krishnasamy M, Plant H, Bailey C, A'Hern R. Multicentre randomised control trial of a nursing intervention for breathlessness in patients with lung cancer. BMJ. 1999;318:901–4.
    1. Hately J, Laurence V, Scott A. et al.Breathlessness clinics within specialist palliative care settings can improve the quality of life and functional capacity of patients with lung cancer. Palliat Med. 2003;17:410–7. doi: 10.1191/0269216303pm752oa.
    1. Booth S, Moffat C, Farquhar M, Higginson IJ, Bausewein C, Burkin J. Developing a breathlessness service for patients with palliative and supportive care needs, irrespective of diagnosis. J Palliat Care. 2011. in press .
    1. MRC. A framework for development and evaluation of RCTs for complex interventions to improve health. London: MRC; 2000.
    1. Farquhar M, Higginson IJ, Fagan P, Booth S. The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease. BMC Palliat Care. 2009;8:9. doi: 10.1186/1472-684X-8-9.
    1. Farquhar M, 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. Palliat Support Care. 2010;8(2):143–9. doi: 10.1017/S1478951509990897.
    1. Terry W, Olson LG, Ravenscroft P, Wilss L, Boulton-Lewis G. Hospice patients' views on research in palliative care. Intern Med J. 2006;36:406–13. doi: 10.1111/j.1445-5994.2006.01078.x.
    1. Gift AG, Narsavage G. Validity of the numeric rating scale as a measure of dyspnea. Am J Crit Care. 1998;7(3):200–4.
    1. Burdon JGW, Juniper EF, Killian FE, Hargreave FE, Campbell EJM. The perception of breathlessness in asthma. Am Rev Respir Dis. 1982;126:825–828.
    1. Corner J, Plant H, Warner L. Developing a nursing approach to managing dyspnoea in lung cancer. Int J Palliat Nurs. 1995;1:5–11.
    1. Guyatt GH, Berman LB, Townsend M, Pugsley SO, Chambers LW. A measure of quality of life for clinical trials in chronic lung disease. Thorax. 1987;42:773–8. doi: 10.1136/thx.42.10.773.
    1. EuroQoL Group. EuroQoL-a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208.
    1. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:361–70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Beecham J, Knapp M. In: Measuring Mental Health Needs. 2. Thornicroft G, editor. London: The Royal College of Psychiatrists; 2001. Costing psychiatric interventions; pp. 200–24.
    1. Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980;20(6):649–55.
    1. Lawton MP, Kleban MH, Moss M, Rovine M, Glicksman A. Measuring caregiving appraisal. J Gerontol. 1989;44(3):61–71.
    1. Ritchie J, Spencer L. In: Analyzing Qualitative Data. Bryman A, Burgess RG, editor. London: Routledge; 1994. Qualitative data analysis for applied policy research; pp. 173–94.
    1. Curtis L, Netten A. Unit costs of health and social care. Canterbury: PSSRU; 2006.
    1. Higginson IJ, Vivat B, Silber E, Saleem T, Burman R, Hart S, Edmonds P. Study protocol: delayed intervention randomised controlled trial within the Medical Research Council (MRC) Framework to assess the efffectiveness of a new palliative care service. BMC Palliat Care. 2006;5:7. doi: 10.1186/1472-684X-5-7.
    1. McWhinney IR, Bass MJ, Donner D. Evaluation of a palliative care service: problems and pitfalls. BMJ. 1994;309:1340–2.
    1. Booth S. MD thesis. University of London; 2008. Improving the Palliative Care of Patients with Intractable Breathlessness.
    1. Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, Guthrie B, Lester H, Wilson P, Kinmonth AL. Designing and evaluating complex interventions to improve health care. BMJ. 2007;334(7591):455–9. doi: 10.1136/.

Source: PubMed

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