Title: A randomised controlled trial to determine the clinical and cost effectiveness of a self-management intervention for the respiratory distress symptom cluster (breathlessness-cough-fatigue) in lung cancer
Funder: Department of Health and Social Care

Abstract: Background: Intrathoracic malignancy (primary tumour and mesothelioma), is the leading cause of death from cancer in the UK. Distressing symptoms of breathlessness, cough and fatigue are a major concern for many patients at all stages of illness. Research has focused on breathlessness, cough or fatigue as single symptoms, yet in reality patients report multiple symptoms. Using the MRC framework for the development of complex interventions we have confirmed the presence of a respiratory distress symptom cluster consisting of breathlessness-cough-fatigue and developed a multi-component self-management intervention (Respiratory Distress Symptom Intervention (RDSI)) that targets all three symptoms in the cluster, delivered as part of routine clinical practice. Our feasibility trial established that a subsequent Phase Three trial of RDSI was feasible with evidence of positive RDSI activity in the main outcome measure for each symptom in the cluster. Furthermore, we have been able to pool experience with others working in the field of complex symptom management interventions and we are now poised to evaluate the clinical and cost-effectiveness of the RDSI in an adequately powered trial. Aims: This study aims to determine the clinical and cost effectiveness of RDSI compared with usual care alone for the self-management of the cluster breathlessness-cough-fatigue in intrathoracic malignancy. Our secondary aims are to determine if RDSI improves patient (and carer) quality of life (QOL) and psychological well-being. Plan of investigation: This is a multi-centre, pragmatic individually randomised parallel group trial. Based on our feasibility data, we plan to recruit 122 patients per arm to have 80% power, at 5% overall significance level, to detect a clinically relevant improvement in the three clustered symptoms of breathlessness, cough and fatigue, allowing for 20% drop-out at 12 weeks. The sample will be recruited over 20 months at six well-established lung cancer sites, seeing over 2,000 new intrathoracic malignancy patients per year; demonstrated to be achievable in the feasibility study with 101 patients recruited in eight months. Randomisation will be stratified by recruitment site, mesothelioma diagnosis (due to a differential clinical phenotype) and radical or palliative treatment intent. RDSI includes four core components (breathing and cough easing techniques, acupressure and individually tailored exercise plan) and is taught to patients (and carers) in two one-hour sessions, delivered one week apart, with a follow-up telephone call two weeks later. Assessments at baseline, Week four and Week 12, will include outcome measures identified as the most useful from our feasibility data: severity and impact of breathlessness, cough, and fatigue, as well as global questionnaires of QoL and psychological well-being. Carers QoL and psychological well-being will also be assessed. Health care resource use data and EuroQol-5D-5L will be collected to assess the cost-effectiveness of RDSI in comparisons to usual care from the perspective of the NHS. Benefits: By targeting multiple symptoms, routine use of RDSI may result in greater clinical and cost-effectiveness than the usual care approach of addressing symptoms in isolation, whilst maximising patients and clinicians efforts. Feasibility data showed that adherence to the different techniques was high and patients (and carers) valued the flexibility, independence and sense of control that a package of interventions for multiple symptoms provided; findings that were further confirmed by our patient advisory group. RDSI could significantly impact on the well-being of patients with intrathoracic malignancy at all stages, including advanced disease and survivors following radical treatment. This could improve multiple-symptom experience and result in a more efficient allocation of health care resources.

Lay abstract: Lung cancer is seldom curable and approximately 33,000 people will die from lung cancer each year in the UK. Many people living with lung cancer have distressing symptoms, including being short of breath, cough and tiredness. It is common for patients to experience all three symptoms together; however previous research has looked at how to help each symptom on its own. This may not be helpful as symptoms often happen together and things can be done to help the symptoms together. To help with all shortness of breath, cough and tiredness together we developed a number of activities to help all three symptoms: the Respiratory Distress Symptom Intervention (RDSI). This treatment includes breathing training, exercise, self-acupressure and other techniques to control cough. We have already completed an earlier study that found the intervention to be practical and acceptable to patients. We want to do further research to see whether the RDSI will improve patients symptoms better than normal treatment. We also want to know more about the effect on quality of life and how patients and their families feel emotionally and whether the intervention is value for money for the NHS. We will undertake a randomised controlled trial, which means an equal number of patients are randomly offered the treatment and the normal care or the normal care only and we can therefore compare both groups. We will include 244 patients across six hospital and patients will be involved in the study for 12 weeks, which includes two education / training sessions (each lasting one hour), and one telephone call. Health professionals at each hospital will be trained to deliver the RDSI, so all patients at every hospital will get the same treatment in the study and teaching hospital staff will help make the RDSI more available to other patients.

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