Title: A randomised trial of high versus low intensity training in breathing techniques for breathlessness in patients with malignant lung disease: early intervention
Funder: Department of Health (England)

Abstract: Background Lung cancer is the commonest cause of death from cancer in the UK (33,000 deaths - 22%- annually). Rarely curable, breathlessness is a major concern in up to 90%. Breathlessness is harder to treat than pain and distresses patients and carers. It limits coping at home when this is crucial. Anxiety/panic is closely related and may trigger emergency hospital admission. Breathing training programmes are helpful, but it is unclear how much training is needed. Repeat training is onerous for frail patients, and costly in terms of therapists. It is therefore vital to clarify the best way of service delivery. We have completed pilot and feasibility work comparing three-session and single session training and are poised to definitively question these findings in this proposed powered study. Aims This study aims to definitively question our feasibility findings. The primary aim is to show that repeated training sessions are more effective in the relief of the severity of breathlessness than a single session, for patients with cancer affecting their lungs. Our secondary aims are to demonstrate superior benefit from repeated breathing sessions in terms of distress caused by the breathlessness, ability to cope with and mastery over breathlessness and patient satisfaction with the management of their breathlessness. We will also assess effect on psychological distress and coping. Using the sample size calculation resulting from our feasibility data we aim to have 80% power to detect a 30% improvement in breathlessness severity (area under the curve), and this allows for 30% drop out. Plan of Investigation We plan to randomise 146 breathless patients with intrathoracic cancer, from 5 recruiting centres, stratified for centre and chemo-radiotherapy, to receive either three “hour-long” sessions at weekly intervals or a single session of standardised breathing training. Recruitment will be through the lung cancer multidisciplinary team. The study intervention was developed using published rehabilitation techniques in consultation with patients involved in our pilot work. Assessments at baseline, weekly till week 4 and then at the study finish at week 8, will include “severity of” and “distress caused by” breathlessness; “coping with” and satisfaction with care of breathlessness using numerical rating scales (NRS). Psychological distress, coping styles and personality type will also be assessed. Potential Impact NICE guidance recommends breathing training for lung cancer patients. Cancer centres have several hundred new lung cancer patients each year, but most breathlessness services only see about 15% of those in need. Many patients have a single session, if any, rather than repeat-session training; our work suggests this is less effective. If all breathless patients with lung cancer were offered repeat session training the NHS cost would be approximately £3.2m per year, but would represent more effective relief of breathlessness, more efficient use of therapist time and potentially reduce use of other health services especially emergency services. This would result in better quality time in their own homes – a patient priority - during their last few months for over 30,000 patients each year.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CANCER AND NEOPLASMS