Respiratory Distress Symptom Intervention (RDSI) Trial

This study aims to determine the effects of adding the Respiratory Distress Symptom Intervention (RDSI) to usual care for the self management of the Respiratory Distress Symptom Cluster (breathlessness-cough-fatigue) for patients with lung cancer including mesothelioma.

Lung cancer is responsible for 33,000 deaths each year in the UK and as disease cure is rarely possible, patient management is often aimed at symptom control. Breathlessness, cough and fatigue are common and distressing symptoms occurring in up to 90%, 47-86% and 50-90% of patients respectively. To date, research in relation to this group of symptoms has focussed on breathlessness, cough or fatigue as single symptoms. However, it is likely that ifa patient suffers from one symptom, they also suffer from one or both of the others. Collectively these symptoms are referred to as the Respiratory Distress Symptom Cluster.

Our group has developed a multi-modal Respiratory Distress Symptom Intervention (RDSI) for the self management of breathlessness, cough and fatigue. This study aims to determine the effects of adding the RDSI to usual care for the self-management of the Respiratory Distress Symptom Cluster for patients with lung cancer.

Patients who take part will be assigned to one of two groups; usual care or usual care plus the RDSI.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of lung cancer - primary tumour, secondary tumour or mesothelioma
2. Suffering from refractory breathlessness or cough or fatigue (presence of a minimum of two of the three symptoms), and which is bothersome to the patient (see below)\*
3. In the presence of COPD, in stable condition
4. WHO Performance Status 0-2
5. Expected prognosis of at least 3 months
6. 18+ years
7. able to give informed consent

   * Patients will be asked as part of the symptom screening process:

Are you affected in your day to day life by breathlessness? Are you affected in your day to day life by cough? Are you affected in your day to day life by fatigue?

Exclusion Criteria:

1. Patients who are experiencing breathlessness, cough and/or fatigue but do not find these symptoms bothersome are not eligible (see below)\*
2. Acute exacerbation\*\* of COPD, or chest infection, within the past 3 weeks, necessitating a change in medication
3. Rapidly worsening breathlessness requiring urgent medical intervention
4. Post chemotherapy and/or radiotherapy to the chest \> 2 weeks
5. Surgical treatment for lung cancer \> 4 weeks

   * Patients will be asked as part of the symptom screening process:

Are you affected in your day to day life by breathlessness? Are you affected in your day to day life by cough? Are you affected in your day to day life by fatigue?

\*\* An exacerbation is defined as a sustained worsening of the patient's symptoms from their usual stable state which is beyond normal day-to-day variations, and is acute in onset. Commonly reported symptoms are worsening breathlessness, cough, increased sputum production and change in sputum colour. The change in these symptoms often necessitates a change in medication. NICE guidelines 201025. In this trial, patients will only be excluded if a change in medications were required - i.e. steroids or antibiotics.