Clinical trial · Interventional
Respiratory Distress Symptom Intervention (RDSI) Trial
A Randomised Controlled Trial to Determine the Clinical and Cost Effectiveness of the Respiratory Distress Symptom Intervention for People With Lung Cancer
NCT03223805CI-TRIAL-00055481RDSI-LCcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Respiratory Distress Symptom Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Control Arm
- description
- Usual Care
- interventionNames
- Other: Respiratory Distress Symptom Intervention
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- Respiratory Distress Symptom Intervention plus Usual Care
- interventionNames
- Other: Respiratory Distress Symptom Intervention
Primary outcomes (3)
- measure
- Breathlessness
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDYorke J, Johnson MJ, Punnett G, Smith J, Blackhall F, Lloyd Williams M, Mackereth P, Haines J, Ryder D, Krishan A, Davies L, Khan A, Molassiotis A. Respiratory distress symptom intervention for non-pharmacological management of the lung cancer breathlessness-cough-fatigue symptom cluster: randomised controlled trial. BMJ Support Palliat Care. 2024 Jan 8;13(e3):e1181-e1190. doi: 10.1136/spcare-2022-003924. PMID 36283797