Rachael Barton

A randomised controlled trial of three or one breathing technique training sessions for breathlessness in people with malignant lung disease

BackgroundAbout 90 % of patients with intra-thoracic malignancy experience breathlessness. Breathing training is helpful, but it is unknown whether repeated sessions are needed. The present study aims to test whether three sessions are better than one for breathlessness in this population.MethodsThis is a multi-centre randomised controlled non-blinded parallel arm trial. Participants were allocated to three sessions or single (1:2 ratio) using central computer-generated block randomisation by an independent Trials Unit and stratified for centre. The setting was respiratory, oncology or palliative care clinics at eight UK centres. Inclusion criteria were people with intrathoracic cancer and refractory breathlessness, expected prognosis ≥3 months, and no prior experience of breathing training. The trial intervention was a complex breathlessness intervention (breathing training, anxiety management, relaxation, pacing, and prioritisation) delivered over three hour-long sessions at weekly intervals, or during a single hour-long session. The main primary outcome was worst breathlessness over the previous 24 hours (‘worst’), by numerical rating scale (0 = none; 10 = worst imaginable). Our primary analysis was area under the curve (AUC) ‘worst’ from baseline to 4 weeks. All analyses were by intention to treat.ResultsBetween April 2011 and October 2013, 156 consenting participants were randomised (52 three; 104 single). Overall, the ‘worst’ score reduced from 6.81 (SD, 1.89) to 5.84 (2.39). Primary analysis [n = 124 (79 %)], showed no between-arm difference in the AUC: three sessions 22.86 (7.12) vs single session 22.58 (7.10); P value = 0.83); mean difference 0.2, 95 % CIs (–2.31 to 2.97). Complete case analysis showed a non-significant reduction in QALYs with three sessions (mean difference –0.006, 95 % CIs –0.018 to 0.006). Sensitivity analyses found similar results. The probability of the single session being cost-effective (threshold value of £20,000 per QALY) was over 80 %.ConclusionsThere was no evidence that three sessions conferred additional benefits, including cost-effectiveness, over one. A single session of breathing training seems appropriate and minimises patient burden.Trial registrationRegistry: ISRCTN; Trial registration number: ISRCTN49387307; http://www.isrctn.com/ISRCTN49387307; registration date: 25/01/2011

Releasing interim results from a randomised clinical trial: an example from the QUARTZ trial

QUARTZ is the first phase III randomised clinical trial of whole brain radiotherapy (WBRT) for patients with inoperable brain metastases from non-small cell lung cancer. It is designed as a non-inferiority trial to assess whether WBRT may be omitted without detriment to the patient’s survival while improving quality of life. QUARTZ opened to recruitment in March 2007 and currently has 76 UK and Australian centres open. Despite universal support of the importance of the question and a number of major initiatives aimed at improving recruitment, by mid-2010 recruitment was slower than targeted and the trial was under threat of closure. It was suggested that one of the reasons for investigators not offering the trial to large numbers of their patients and for patients rejecting randomisation, was the lack of good quality preliminary randomised data to support the trial question. Therefore it was proposed to make the unusual step to release interim results from the trial in order to provide investigators with further information upon which to base trial decisions and discussions.

111 Quality of life after treatment for brain metastases: interim data from the MRC QUARTZ clinical trial. Part two, symptoms, quality of life and data completion

111 Quality of life after treatment for brain metastases: interim data from the MRC QUARTZ clinical trial. Part two, symptoms, quality of life and data completion P. Mulvenna1, R. Barton2, C. Faivre-Finn3, P. Wilson4, R. Langley5, C. Pugh5, M. Nankivell5. 1Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, United Kingdom, 2Castle Hill Hospital, Hull, United Kingdom, 3The Christie, Manchester, United Kingdom, 4University Hospitals Bristol, Bristol, United Kingdom, 5MRC Clinical Trials Unit, London, United Kingdom

Quality of life after radiotherapy and steroids in patients with inoperable brain metastases from non-small cell lung cancer: the QUARTZ trial

Mesothelioma Framework, launched by the Department of Health Lung Cancer and Mesothelioma Advisory Group (LCMAG) in February 2007, aims to provide Strategic Health Authorities (SHA’s), Cancer Networks, Primary Care Trusts (PCT’s) and NHS Trusts advice and guidance on how to better organise mesothelioma services in order to standardise and improve the quality of care throughout the UK. The M-NAT initiative will provide an opportunity for nursing services for people with mesothelioma to be developed to a uniformly high level across the country. To date M-NAT has 43 members representing Scotland, Wales and every English cancer network except one. This core membership is able to cascade information and support to the wider community of nurses working within their network. M-NAT has met three times and two more dates are scheduled for 2009. Regular contact with, and support of, the membership is maintained by e-mail communication. The team has undertaken a detailed review of the Mesothelioma Framework and set its initial priorities: • To develop as a national team • To develop a national mesothelioma patient information pack • To develop a national nursing care pathway for patients • To develop a programme of nursing audit and research in mesothelioma. A baseline survey of members has also been undertaken identifying members’ characteristics, level of understanding, knowledge, skills and confidence in meeting the needs of mesothelioma patients and their carers, as well as their expectations and hopes for M-NAT. This poster will describe the M-NAT initiative in greater detail.