Management of the respiratory distress symptom cluster in lung cancer: a randomised controlled feasibility trial

Abstract

BackgroundBreathlessness, cough and fatigue are distressing symptoms for patients with lung cancer. There is evidence that these three symptoms form a discreet symptom cluster. This study aimed to feasibly test a new non-pharmacological intervention for the management of the Respiratory Distress Symptom Cluster (breathlessness-cough-fatigue) in lung cancer.MethodThis was a multi-centre, randomised controlled non-blinded parallel group feasibility trial. Eligible patients (patients with primary lung cancer and ‘bothered’ by at least two of the three cluster symptoms) received usual care plus a multicomponent intervention delivered over two intervention training sessions and a follow-up telephone call or usual care only. Follow-up was for 12 weeks, and end-points included six numerical rating scales for breathlessness severity, Dyspnoea-12, Manchester Cough in Lung Cancer scale, FACIT-Fatigue scale, Hospital Anxiety and Depression scale, Lung Cancer Symptom Scale and the EQ-5D-3L, collected at baseline, week 4 and week 12.ResultsOne hundred seven patients were randomised over 8 months; however, six were removed from further analysis due to protocol violations (intervention group n = 50 and control group n = 51). Of the ineligible patients (n = 608), 29 % reported either not experiencing two or more symptoms or not being ‘bothered’ by at least two symptoms. There was 29 % drop-out by week 4, and by week 12, a further two patients in the control group were lost to follow-up. A sample size calculation indicated that 122 patients per arm would be needed to detect a clinically important difference in the main outcome for breathlessness, cough and fatigue.ConclusionsThe study has provided evidence of the feasibility and acceptability of a new intervention in the lung cancer population and warrants a fully powered trial before we reach any conclusions. The follow-on trial will test the hypothesis that the intervention improves symptom cluster of breathlessness, cough and fatigue better than usual care alone. Full economic evaluation will be conducted in the main trial.

Participation in a randomised controlled feasibility study of a complex intervention for the management of the Respiratory Symptom Distress Cluster in lung cancer: patient, carer and research staff views

“…Ensuring that potential research participants are fully informed about research expectations, including paper work completion, forms part of the Good Clinical Practice training programme, and was adhered to in this study. For the follow‐on trial, key outcome measures have been identified and participant response burden should reduce due to the decrease in the number of patient and carer‐reported outcomes (Yorke et al., 2015). …”

“…The main results of the RCT feasibility trial are reported elsewhere (Yorke et al., 2015). RDSI had three core components focusing on, (1) breathing techniques, (2) cough easing techniques and (3) acupressure.…”

Assessment of Breathlessness in Lung Cancer: Psychometric Properties of the Dyspnea-12 Questionnaire

“…This was a multi-centre, non-blinded feasibility RCT conducted in the UK [24]. It aimed to feasibility test a non-pharmacological intervention for managing the lung cancer respiratory distress symptom cluster (breathlessness-cough-fatigue).…”

“…A total of 107 lung cancer patients joined the study and 101 were included in the analysis. Participants completed self-reported outcome measures including a range of scales to assess symptoms, psychological distress and QoL [24]. In the current study, only baseline data were used for the analysis.…”

“…Psychometric properties of the D- 12 have not yet been assessed in lung cancer. Therefore, the aim of this study was to determine the validity and reliability of the D-12 in lung cancer, by using data from a recent feasibility randomised controlled trial (RCT) [24].…”