Condition category
Cancer
Date applied
25/10/2011
Date assigned
23/01/2012
Last edited
09/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.christie.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

09/03/2016: Verified study information with principal investigator. 26/02/2016: No publications found, verifying study status with principal investigator.