Plain English Summary
Prof Alex Molassiotis
School of Nursing
Midwifery & Social Work
University of Manchester
Jean McFarlane Building
+44 (0)161 306 7830
The Characterization and treatment of cough in Lung Cancer: a longitudinal survey
1. Cough is prevalent in patients with lung cancer. It can be subjectively and objectively measured over time using validated cough assessment tools that will be applicable to future trials assessing cough
2. Cough prevalence has a negative impact on the quality of life (QoL) of lung cancer patients and is influenced by factors due to the patient (such as continued smoking, co-morbid conditions, concurrent medications) and factors due to the tumour (location, stage, histology).
NRES Committee NW - Greater Manchester South, 11 August 2011, ref: 11/NW/0374
Prospective longitudinal observational cohort study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Cough in Lung Cancer
Day 0 Groups A and B: Case Report Form will be completed by investigator, Brief Reflux Inventory, Visual Analogue Scale (VAS), Manchester Cough in Lung Cancer Scale questionnaire and Quality of LIfe (QOL) questionnaire. Spirometry will be performed on all patients. In Group B, the ambulatory cough monitor will be fitted.
Day 1 Group B: Ambulatory cough monitor removed.
Day 30 (+/- 7 days) Groups A and B: A telephone assessment to conduct the Manchester Cough in Lung Cancer Scale questionnaire and to instruct the patient to complete a VAS on the day at home. Patients will have been given a VAS on Day 0 to complete on day 30 at home. Case Report Form re: antitussives, opiates or angiotensin converting enzymes (ACE) inhibitors and current anticancer treatment will be completed by the study investigator.
Day 60 (+/ 7 days) Groups A and B: A VAS, Manchester Cough in Lung Cancer Scale questionnaire, investigator and QOL questionnaire will be completed. Case Report Form re: treatment data will be completed by the study investigator. Spirometry will be performed on all patients. A cough monitor will be refitted in group B.
Day 61 Group B : Ambulatory cough monitor removed.
This coincides with routine treatment appointments to minimise extra patient visits.
Primary outcome measures
1. Frequency of cough, measured using 24-hour ambulatory cough monitoring at baseline and day 60 in a subset of patients
2. Severity of cough, measured using the Cough Severity Visual Analogue Scale at baseline, day 30 and day 60; the Cough Severity Diary at baseline and day 60; and the EORTC LC13 questionnaire at baseline and day 6060 and the Common Toxicity Criteria for Adverse Events v 4.0 at baseline and day 60
Secondary outcome measures
1. Impact of cough on quality of life measured using the Manchester Cough in Lung Cancer Scale at baseline, day 30 and day 60
2. Clinical factors associated with cough severity and cough impact scores at baseline and day 60
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
2. WHO performance 0-2
3. Ability to give informed consent to participate
4. Age ≥18 years
Target number of participants
Participant exclusion criteria
Patients unable to complete self-reporting questionnaires
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
The Christie NHS Foundation Trust
Trial participating centre
University Hospitals of South Manchester NHS Trust
National Institute for Health Research (NIHR) (UK) (ref: DRF-2010-03-55)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication of Characterisation of Cough in Lung Cancer to Thorax with results of trial and Further Evaluation of Manchester Cough in Lung Cancer Scale.
1. Results published in thesis 2015 https://www.research.manchester.ac.uk/portal/files/59982486/FULL_TEXT.PDF
2. Results presented at British Thoracic Society Winter Meeting 2013 http://thorax.bmj.com/content/68/Suppl_3/A101.2
Intention to publish date
Participant level data
Available on request
Results - basic reporting