TY - JOUR
T1 - Respiratory distress symptom intervention for non-pharmacological management of the lung cancer breathlessness-cough-fatigue symptom cluster
T2 - randomised controlled trial
AU - Yorke, Janelle
AU - Johnson, Miriam J
AU - Punnett, Grant
AU - Smith, Jaclyn
AU - Blackhall, Fiona
AU - Lloyd Williams, Mari
AU - Mackereth, Peter
AU - Haines, Jemma
AU - Ryder, David
AU - Krishan, Ashma
AU - Davies, Linda
AU - Khan, Aysha
AU - Molassiotis, Alex
N1 - Funding Information:
This study was funded by the National Institute for Health Research, Research for Patient Benefit (PB-PG-1014-35045).
Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/10/25
Y1 - 2022/10/25
N2 - 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.
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.
KW - dyspnoea
KW - fatigue
KW - lung
U2 - 10.1136/spcare-2022-003924
DO - 10.1136/spcare-2022-003924
M3 - Article
C2 - 36283797
SN - 2045-435X
JO - BMJ supportive & palliative care
JF - BMJ supportive & palliative care
M1 - 003924
ER -
