The characterization and treatment of cough in lung cancer

ISRCTN	ISRCTN72828211
DOI	https://doi.org/10.1186/ISRCTN72828211
Protocol serial number	11_DOG07_129
Sponsor	The Christie NHS Foundation Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) (ref: DRF-2010-03-55)

Submission date: 25/10/2011
Registration date: 23/01/2012
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-find-out-more-about-coughing-people-with-lung-cancer-clic-study

Contact information

Prof Alex Molassiotis
Scientific

School of Nursing, Midwifery & Social Work
University of Manchester
Jean McFarlane Building
Room 5.310
Oxford Road
Manchester
M13 9PL
United Kingdom

Phone	+44 (0)161 306 7830
Email	alex.molasiotis@polyu.edu.hk

Study information

Primary study design	Observational
Study design	Prospective longitudinal observational cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	The Characterization and treatment of cough in Lung Cancer: a longitudinal survey
Study acronym	CLiC
Study objectives	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(s)	NRES Committee NW - Greater Manchester South, 11 August 2011, ref: 11/NW/0374
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	180
Total final enrolment	177
Key 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
Key exclusion criteria	Patients unable to complete self-reporting questionnaires
Date of first enrolment	05/10/2011
Date of final enrolment	01/06/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

The Christie NHS Foundation Trust

Wimlsow Road
Manchester
M20 4BX
United Kingdom

University Hospitals of South Manchester NHS Trust

Southmoor Road
Manchester
M23 9LT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2019	24/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
24/01/2019: Publication reference added
30/04/2018: Thesis and conference abstract added to publication and dissemination plan.
09/03/2016: Verified study information with principal investigator.
26/02/2016: No publications found, verifying study status with principal investigator.