Phase III Randomized Controlled Trial of a Breathlessness Intervention Service for Intractable Breathlessness.

Research questions:

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 & carer distress due to breathlessness, & increase patients' sense of mastery of the symptom?
3. What are the experiences & views of those who use BIS, their informal carers & the clinicians who refer to it?
4. Is BIS cost-effective?

To assess changes in patient outcomes attributable to BIS, a pragmatic RCT design will be conducted using a fast-track design (design proved highly acceptable at Phase II). Analysis will focus on comparing patients who have used BIS to those who have not (yet) used BIS (the use of BIS by the control group will occur subsequent to these measurement points).

The researcher will be blinded to the allocation of respondents up until discharge/referral on from BIS for FT patients or at the end of the waiting period for CC patients. This will be achieved by the researcher conducting study recruitment & collecting baseline measures before instructing a third party (local clinical trials' nurse) to conduct randomisation & reporting of allocation (to the patient & BIS) using a random sequence of opaque envelopes previously generated by a statistician independent of BIS. Subsequently, all data will be handled using study identity numbers; group allocation identifiers will only be added at analysis. This model was used successfully in the Phase II pilot trial.

Data collected from the control group once they are in receipt of BIS (after their period on the waiting list when their group allocation was blinded to the researcher) will be treated as before/after data & not RCT data. This will allow the collection of qualitative data from this group at the midpoint of using BIS.