Respiratory Distress Symptom Intervention (RDSI) Trial (RDSI-LC)
Lung Cancer
About this trial
This is an interventional supportive care trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of lung cancer - primary tumour, secondary tumour or mesothelioma
- 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)*
- In the presence of COPD, in stable condition
- WHO Performance Status 0-2
- Expected prognosis of at least 3 months
- 18+ years
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:
- Patients who are experiencing breathlessness, cough and/or fatigue but do not find these symptoms bothersome are not eligible (see below)*
- Acute exacerbation** of COPD, or chest infection, within the past 3 weeks, necessitating a change in medication
- Rapidly worsening breathlessness requiring urgent medical intervention
- Post chemotherapy and/or radiotherapy to the chest > 2 weeks
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.
Sites / Locations
- The Christie NHS Foundation Trust
- University Hospital South Manchester
- Heartlands Hospital, Heart of England NHS Foundation Trust
- Castle Hill Hospital, Hull and East Yorkshire Hospitals NHS Foundation Trust
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Scarborough General Hospital, York Teaching Hospital NHS Foundation Trust
- The Clatterbridge Cancer Centre NHS Foundation Tust
Arms of the Study
Arm 1
Arm 2
Other
Experimental
Control Arm
Intervention Arm
Usual Care
Respiratory Distress Symptom Intervention plus Usual Care