PT - JOURNAL ARTICLE AU - Janelle Yorke AU - Miriam J Johnson AU - Grant Punnett AU - Jaclyn Smith AU - Fiona Blackhall AU - Mari Lloyd Williams AU - Peter Mackereth AU - Jemma Haines AU - David Ryder AU - Ashma Krishan AU - Linda Davies AU - Aysha Khan AU - Alex Molassiotis TI - Respiratory distress symptom intervention for non-pharmacological management of the lung cancer breathlessness–cough–fatigue symptom cluster: randomised controlled trial AID - 10.1136/spcare-2022-003924 DP - 2022 Oct 25 TA - BMJ Supportive & Palliative Care PG - spcare-2022-003924 4099 - http://spcare.bmj.com/content/early/2023/05/04/spcare-2022-003924.short 4100 - http://spcare.bmj.com/content/early/2023/05/04/spcare-2022-003924.full AB - Objectives In lung cancer, three prominent symptoms, such as breathlessness, cough and fatigue, are closely related with each other forming a ‘respiratory distress symptom cluster’. The aim of this study was to determine the clinical and cost-effectiveness of the respiratory distress symptom intervention (RDSI) for the management of this symptom cluster in people with lung cancer.Methods A single blind, pragmatic, randomised controlled trial conducted in eight centres in England, UK. A total of 263 patients with lung cancer were randomised, including 132 who received RDSI and 131 who received standard care. To be eligible, participants self-reported adverse impact in daily life from at least two of the three symptoms, in any combination. Outcomes were change at 12 weeks for each symptom within the cluster, including Dyspnoea-12 (D-12), Manchester Cough in Lung Cancer (MCLC) and Functional Assessment of Chronic Illness-Fatigue.Results At baseline, nearly 60% of participants reported all three symptoms. At trial completion the total trial attrition was 109 (41.4%). Compared with the control group, the RDSI group demonstrated a statistically significant improvement in D-12 (p=0.007) and MCLC (p<0.001). The minimal clinically important difference MCID) was achieved for each outcome: D-12 –4.13 (MCID >3), MCLC −5.49 (MCID >3) and FACIT-F 4.91 (MCID >4).Conclusion RDSI is a clinically effective, low-risk intervention to support the management of the respiratory distress symptom cluster in lung cancer. However, the study did experience high attrition, which needs to be taken onto consideration when interpreting these results.Trial registration number NCT03223805.Data are available on reasonable request.