A study to find out more about coughing in people with lung cancer (CLiC study)

This study is to understand more about cough in people with lung cancer, to help doctors one day be able to work out the best way to treat this symptom. Having a cough is a very common symptom in people who have cancer affecting the lungs.

We know that coughing can affect many areas of daily life. For example, it can make communicating clearly more difficult, and cause poor appetite, sleeplessness, vomiting, severe tiredness, pain, anxiety, fainting, and even loss of control over passing urine. Researchers in this study want to understand more about cough in people with lung cancer, so they can work out how to improve people’s quality of life. They will ask people about their cancer, test how well their lungs work and in some people monitor their cough for two 24 hour periods. The aims of this study are to find out

How common cough is in people with lung cancer
How severe it is
The impact it has on people’s quality of life

They hope that the information they gain from the study will help them design trials to work out treatment for cough in lung cancer in the future.

Recruitment

Start 05/10/2011

End 30/06/2012

Phase

Other

Who can enter

You may be able to enter this study if you

Have either small cell lung cancer or non small cell lung cancer
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Are at least 18 years old

You cannot enter this study if you would not be able to complete the study questionnaires for any reason.

Trial design

This study will recruit 178 people into either group A or group B.

If you are being cared for by the Christie Hospital, Manchester you will be in group A.

If you are being cared for at the Wythenshawe Hospital, Manchester, you will join group B.

The only difference between the 2 groups is that people in group B will have their cough monitored by a special device that they wear overnight at home and have removed the next day. Only people in group B will have their cough monitored, because the equipment and team are at Wythenshawe Hospital. If you are at the Wythenshawe Hospital but either can’t or don’t want to have your cough monitored, you will be put into group A.

Everyone in this trial fills out questionnaires about their cough. This will include marking on a scale of 1 to 10 how bad your cough is. The questions will ask about

How bad your cough is and how it affects your quality of life
Your general health, symptoms and mood
Your medication and any smoking history

You give permission for the team to collect information from your medical notes about your lung cancer, treatment and medical history. You also blow into a hand held device that shows the team how well your lungs are working. This test should only take 5 minutes. If you are too breathless, you will not have to do this test. This whole visit should take about 30 minutes.

After a month, the team will phone you at home, and ask you some more questions about your cough, medication and cancer treatment. This call should not take more than 5 minutes.

A month after this, you come back to the clinic. You complete the same questionnaires and lung test as you did at the first visit.

If you are in group B, the team will also monitor your cough. They will record the number of times you have coughed, and how long for. At both visits they will put a small microphone on your chest, and another one on your clothes. You wear the monitor around your waist for 24 hours. The monitor can filter out most background sounds, but as well as picking up and recording your cough, it will pick up and record anything you say during this time.

The recordings will be kept confidentially. But if the researcher hears anything in the recording that may place you or another person in danger, they would have to report this.

You repeat all the tests and visits in the same way as those in group A. The only difference is that you come back to hospital the day after having your cough monitor fitted, to have it removed.

Hospital visits

The team will try to make sure that the study visits are on the same day as a hospital visit you already have planned.

If you are in group B you will need to make an extra hospital visit both times you have the monitor fitted, to have it removed. But if you are too unwell, the researcher will come to your home to collect the monitor.