The characterization and treatment of cough in lung cancer
ISRCTN | ISRCTN72828211 |
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DOI | https://doi.org/10.1186/ISRCTN72828211 |
Secondary identifying numbers | 11_DOG07_129 |
- 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
Plain English summary of protocol
Contact information
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 |
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alex.molasiotis@polyu.edu.hk |
Study information
Study design | Prospective longitudinal observational cohort study |
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Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital |
Study type | Screening |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 05/10/2011 |
Completion date | 01/06/2012 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
- England
- United Kingdom
Study participating centres
Manchester
M20 4BX
United Kingdom
Manchester
M23 9LT
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Ms Angela Ball
Research and Development Department
Wilmslow Road
Manchester
M20 4BX
England
United Kingdom
Phone | +44 (0)161 446 3000 |
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holly.white@christie.nhs.uk | |
Website | http://www.christie.nhs.uk/ |
https://ror.org/03v9efr22 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
Intention to publish date | 31/03/2017 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
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. 30/04/2018: 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 |
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 |
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.