Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Prof Alex Molassiotis
ORCID ID
Contact details
School of Nursing
Midwifery & Social Work
University of Manchester
Jean McFarlane Building
Room 5.310
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 7830
alex.molasiotis@polyu.edu.hk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11_DOG07_129
Study information
Scientific title
The Characterization and treatment of cough in Lung Cancer: a longitudinal survey
Acronym
CLiC
Study hypothesis
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).
Ethics approval
NRES Committee NW - Greater Manchester South, 11 August 2011, ref: 11/NW/0374
Study design
Prospective longitudinal observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cough in Lung Cancer
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
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
05/10/2011
Overall trial end date
01/06/2012
Reason abandoned
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
180
Participant exclusion criteria
Patients unable to complete self-reporting questionnaires
Recruitment start date
05/10/2011
Recruitment end date
01/06/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Christie NHS Foundation Trust
Wimlsow Road
Manchester
M20 4BX
United Kingdom
Trial participating centre
University Hospitals of South Manchester NHS Trust
Southmoor Road
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
The Christie NHS Foundation Trust (UK)
Sponsor details
c/o Ms Angela Ball
Research and Development Department
Wilmslow Road
Manchester
M20 4BX
United Kingdom
+44 (0)161 446 3000
holly.white@christie.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) (ref: DRF-2010-03-55)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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.
Intention to publish date
31/03/2017
Participant level data
Available on request
Results - basic reporting
Publication summary