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Study protocol : Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease . 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 .
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Intervention_Other
Breathlessness Intervention Service ( BIS )
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Intervention_Other
complex intervention
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Intervention_Other
non-pharmacological
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Intervention_Control
standard care
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Intervention_Physical
two broad service models
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Intervention_Educational
Mixed method interviews
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Intervention_Physical
palliative care
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Outcome_Physical
breathlessness in advanced disease
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Outcome_Physical
distress to patients
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Outcome_Physical
management challenges to health care professionals
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Outcome_Physical
care of breathless patients
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Outcome_Physical
'patient distress due to breathlessness ' measured on a numerical rating scale ( 0-10 )
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Outcome_Other
economic evaluation
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Outcome_Other
clinical and cost-effectiveness of the service
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Participant_Condition
breathlessness in advanced disease
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Participant_Condition
breathless patients with advanced disease ( regardless of cause )
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Participant_Condition
malignant disease
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Participant_Condition
non-malignant disease
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Participant_Condition
malignant conditions
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Participant_Condition
non-malignant conditions