C111
Breathlessness training in patients with intrathoracic malignancy: a comparison of low and high intensity programmes
Miriam Johnson, Anne English, Sam Nabb, Alan Rigby, Rachael Barton
1Hull York Medical School, Hull, UK, 2Dove House Hospice, Hull, UK, 3University of Hull, UK, 4Hull and East Yorkshire Hospitals NHS Trust, Hull, UK
Background
This feasibility study aimed to assess recruitment and retention, best end point and variability of breathlessness scores in order to calculate sample size for a future study. The planned follow-on study aims to assess whether a series of breathlessness training sessions improves breathlessness better than a single session.
Method
This was a single centre, randomised controlled non-blinded parallel group feasibility study. Eligible participants (breathless patients with intra-thoracic malignancy) were randomised to receive 3 breathlessness management training sessions or a single session only. Follow-up was for 8 weeks and endpoints were: numerical rating scales (NRS) of breathlessness severity; breathlessness distress; HAD questionnaire; coping (Brief COPE and our NRS coping question); EQ-5D and VAS.
Results
22 patients were randomised over 12 months; 55% of expected recruitment from pilot data. There was 40% drop-out by week 4. Screening logs indicated this resulted from excluding patients having chemo-radiation. The most useful NRS scores for breathlessness severity were for worst and average over past 24 hours. Breathlessness now was less useful. From variability data for worst breathlessness, a sample size of 270 should allow detection of a 30% improvement in area under the curve in the high intensity group compared with low, (90% power; p= 0.05, two-tailed; 2:1 randomisation low:high) allowing 50% drop out at 4 weeks.
Conclusion
The follow-on 8 centre study will include patients undergoing chemo-radiation to allow better recruitment. There will be stratification by centre to allow for differences in rates of chemo-radiation and variations in breathlessness service configuration.
