A complex non-pharmacological intervention for breathlessness-cough-fatigue: results from a feasibility RCT
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A complex non-pharmacological intervention for breathlessness-cough- fatigue: results from a feasibility RCT Dr Janelle Yorke Senior Lecturer, School of Nursing, Midwifery and Social Work University of Manchester Honorary Senior Lecturer, University Hospital South Manchester
The Research Team • Professor Alex Molassiotis (Palliative Care, Nursing, Hong Kong) • Professor Mari Lloyd-Williams (Consultant Palliative Medicine, Liverpool University) • Professor Jacky Smith (Respiratory Physician – Cough, UHSM) • Professor Ann Cares (Nursing, UoM) • Professor Karen Luker (Community Nursing, UoM) • Dr Peter Mackereth (Complimentary Therapist, Christie) • Dr Amelie Harle (Palliative Care Registrar, Christie) • Dr Fiona Blackhall (Consultant Oncologist, Christie) • Jemma Haines (Speech and Language Therapist, UoM) • Dr Chris Bailey (Nursing, Southampton University) • Mark Pilling (Statistician, UoM) • Jackie Ellis (Research Associate, Liverpool University) • June Warden (Research Associate, UoM) • David Ardron (Patient representative)
Introduction • Lung cancer is the commonest cause of death from cancer worldwide • Associated with significant symptom burden • Breathlessness • Cough • Haemoptysis • Nausea • Vomiting • Fatigue • Anxiety • Depression • Sleep disturbance
Introduction • Developing evidence for presence of ‘symptom- clusters’ • 2 or more concurrent symptoms that are related and may or may not have a common cause (Dodd et al 2001:OncolNursForum) • Lung cancer: nausea+vomiting & breathless+cough • Respiratory symptom cluster: Breathlessness-Cough-Fatigue (Molassiotis et al 2010:J Pain Symptom Manage; Molassiotis et al 2011:Lung Cancer)
Introduction • Developing evidence base for non-pharmacological management of single symptoms: • Breathlessness (Molassiotis et al. 2010:Respir Med; Bailey et al. 2010: BMC Pulm Med; Yorke et al. 2012:Chron Resp Dis) • Cough (Molassiotis et al. 2010: Cochrane; Yorke et al. 2012:Chron Resp Dis) • Fatigue (Ernst et al. 2001: Amer J Med; Mayhew et al. 2007: Rheumatology)
Respiratory Symptom Distress Cluster
Cough
BreathlessnessIntervention development: key points - patients • Flexibility within an intervention: symptomatology varied and patients wanted flexibility and choice • Practicality of intervention components: need to fit in easily with normal daily activities • Patients were interested in techniques that would help with specific problems • Caregiver involvement: advantages – however patients are also concerned with maintaining autonomy Ellis et al. 2012:J Pain Symptom Manage
Intervention development: key points - HCPs • Some not confident to teach non-pharmacological interventions without additional training • The later in the disease progression the more difficult it is to teach interventions • Ideally teach before symptoms become severe • Often a small window of opportunity • Questions of space/time/repeat training Ellis et al. 2012:J Pain Symptom Manage
Intervention development Respiratory Symptom Cluster Intervention (RSCI) includes components that patients and carers previously expressed preference for: I. Breathing techniques II. Cough easing techniques III. Acupressure IV. Supplementary booklet/information
Acupressure points
L14 L9 CV20&21
ST36RSCI: feasibility randomised controlled trial Objectives • To assess intervention feasibility / acceptability • To test the design and practicality of the protocol with regard to recruitment, attrition, adherence • To identify the most appropriate symptom measures and calculate sample size for a fully powered trial • To assess the feasibility of recruiting carers and collecting relevant outcomes
Methods • Participants recruited from out-patient clinics (initially 4 sites > 11 sites across North West) • Intervention delivered by a range of HCPs in the community near to or at patients home • Patients (and carers) were taught core components during two face-to-face sessions, one week apart and one follow-up telephone (week 4) • Control group received usual care
Methods
• Inclusion criteria:
• Primary lung cancer, attending an out-patient clinic
• Reported being ‘bothered’ by at least 2 of the 3 cluster
symptoms
• Expected prognosis of at least 3 months
• Patients asked if they would like to nominate a carer
• Exclusion criteria:
• < 4 weeks COPD exacerbation or chest infection that
necessitated a change in medication
• < 4 weeks post chemo/radiotherapyMethods
Outcome assessments
• Collected at baseline, week 4 and week 12:
• Breathlessness
• NRS (0-10) for average, worst, distress, coping, relief
• Dyspnoea-12 (total score 0-36; physical and affective domains)
• Cough
• Manchester Cough in Lung Cancer Scale (10 items, total score 1-40)
• Fatigue
• The FACIT-Fatigue (13 items, total score 0-52)
• Other outcomes
• Lung Cancer Symptom Scale – 9 VAS scores
• Brief-Cope
• Hospital Anxiety and Depression scale (HAD)
• EQ-5D (Index and VAS)
• RSCI group – daily diary x4 weeks, then weekly x12 weeks
• Interviews with patients/carers/HCPsMethods Sample size: • Convention of 30 patients per arm at final follow-up (Lancaster 2004), with 50% attrition expected at week 12 • Randomise 60 patients per arm(120 total) (60 carers)
Results
Screened = 487 Ineligible = 380
176 – symptom/s absent or not bothersome
Randomised = 107 74 declined, 5 no reason
130 recent treatment, 55 required further treatment
40 poor prognosis
RSCI n = 53 Control n = 54
Excluded n = 3 Excluded n = 3
Did not complete RSCI n=7 Total = 50 Total = 51
1 RIP, 4 unwell, 1 shingles,
1 Drop-out
Did not complete wk 4 Did not complete wk 4 n=10
n=12
Week 4 Week 4 5 RIP, 5 Drop-out
1 RIP, 11 Drop-out Completed n = 31 Completed n = 41
Did not complete wk 12 n= 1
Week 12 Week 12
Completed n = 31 Completed n = 40
Carers n = 26 Carers n = 27
Completed wk 12 n = 16 Completed wk 12 n = 14Baseline characteristics
(all frequency and %, unless otherwise stated) Control n = 51 RSCI n = 50
Age mean(SD) 67.6 (9.1) 67.8 (10.1)
Sex: Male 25 (49.0) 22 (44.0)
Female 26 (51.0) 28 (56.0)
Number of symptoms: 2/3 22 (43.1) 18 (36.0)
3/3 29 (56.9) 32 (64.0)
Presence of individual symptoms
Breathlessness
Present 50 (98.0) 49 (98.0)
Bothersome 50 (100.0) 48 (98.0)
Cough
Present 41 (80.4) 40 (80.0)
Bothersome 32 (78.0) 35 (83.3)
Fatigue
Present 51 (100.0) 48 (96.00
Bothersome 49 (96.1) 48 (100.0)
Cancer treatment group
1: no further active cancer therapy 7 (13.7) 5 (10.0)
2: post curative treatment 18 (35.3) 19 (38.0)
3: palliative cancer therapy follow-up 26 (51.0) 26 (52.0)Results
Adherence to RSCI
• Diary completion ranged from 19 and 32 patients
• Breathing exercises:
• Up to week 4: daily 87%-100%
• Up to week 12: weekly 96%-100%
• Acupressure:
• Up to week 4: daily 84%-100%
• Up to week 12: weekly 91%-96%
• Cough easing:
• Up to week 4: daily 32%-63%
• Up to week 12: weekly 36%-54%Results: Breathlessness NRS
Average breathlessness
Worst breathlessness 24hrs Distress from breathlessness
Ability to cope with breathlessnessResults: Change scores- Dyspnoea-12
Dyspnoea-12 Total
Dyspnoea-12 Physical Dyspnoea-12 AffectiveResults: Change scores - Cough & Fatigue
Cough-MCLCS
Fatigue-FACITResults - qualitative Interviews: 11 patients and 2 carers • Greater understanding of their illness and symptoms • Relief that symptoms were not ‘unique’ to them • Some initial scepticism - soon felt they had a greater sense of control in their ability to manage symptoms including anxiety • Techniques “not intrusive” and patients used them “as and when” they felt the need • Acupressure difficult to grasp initially • Feeling unwell – barrier to practising techniques.
Conclusions • Unique – ‘package’ of different techniques to manage the respiratory symptom cluster • High levels of treatment adherence reported • Challenging to identify most appropriate outcome • Breathlessness appears to be the driver for the cluster • NRS ‘coping’ and Dyspnoea-12 key outcomes • Fatigue least sensitive to intervention • This study provided evidence of the feasibility and acceptability of the RSCI in lung cancer
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