A study to learn more about lung cancer in people who smoke (LungCAST)

This study is looking at whether smoking after diagnosis with lung cancer affects your outcome.

We know from research that stopping smoking reduces risk of lung cancer. But researchers in this study believe that smoking after diagnosis may affect the course of the condition. They think it could be possible that smoking affects levels of anti cancer treatment in the blood and body tissue. We know from other laboratory research that there is a link between smoking and cancers that are more resistant to chemotherapy. And that smoking can affect oxygen levels in cancers, affecting how well radiotherapy works.

This study is split into 2 parts. The first will observe a group of smokers and non smokers with lung cancer for up to 2 years. Part 2 of the study is a trial looking at different types of stop smoking support. The team will monitor how well everyone is getting on by using questionnaires and breath testing for a chemical found in cigarettes called carbon monoxide. They will also gather information about whether people are still smoking, whether their cancer has got worse or better, any treatment problems they are having and how they are. The aims of this study are to see

If smoking after a diagnosis of lung cancer affects survival
Whether seeing a hospital based stop smoking specialist improves survival, compared to having one off advice from the doctor, in smokers with lung cancer

Recruitment

Start 01/03/2011

End 29/03/2014

Phase

Other

Who can enter

This study is split into 2 parts that will run at the same time. It may be possible to take part in both studies if you are suitable to do so.

You may be able to enter part 1, the observation study, if you

Have cancer that started in the lungs
Are able to have a series of breath tests to measure levels of carbon monoxide (found in cigarette smoke)

You may be able to enter part 2 of the study, comparing different types of stop smoking advice, if you

Have cancer that started in your lungs
Are a smoker
Are at least 18 years of age

You cannot enter part 2 if you

Would not be willing or able to have a series of breath tests to measure levels of carbon monoxide
Have a mental health condition that is a cause for concern
Have a history of drug misuse
Have any other cancer, apart from non melanoma skin cancer
Would not be able to travel to the stopping smoking counsellor or to your hospital appointments
Are in bed for most of the day and need a lot of looking after (performance status of 4)

Trial design

This study will recruit 2,400 people altogether.

Everyone will join in part 1 of the study. The team will ask you questions about smoking habits from the past and now. You then breathe into a tube attached to a small hand held monitor, which measures carbon monoxide levels in your breath.

You will also fill out a questionnaire which will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study. The questionnaire and breath test together take less than 5 minutes. You have a breath test and fill out one of these questionnaires every time you come to clinic for your usual follow up appointments, for up to 2 years.

Part 2 of the study is a randomised trial. If you agree to take part in this trial, your doctor will open an envelope which will say that you will join either

Group 1 - get advice from your doctor, with or without medication to help you stop smoking
Group 2 - visit the stopping smoking specialist

If you are in group 1, you will see the doctor once for advice on stopping smoking.

If you are in group 2, you will have a couple of sessions with the specialist. They will offer you medication to help you stop smoking, and phone you between visits to offer support.

Whichever group you are in, you will also have breath tests and fill out quality of life questionnaires when you see the study team.

After 2 years, you will not have any more breath tests and questionnaires, but the team will continue to review you in clinic, as part of your usual care.

Hospital visits

Where possible, you will see the study team (and the stopping smoking specialist if this applies to you) when you come for your routine hospital appointments. These will be around 1, 3, 6, 12 and 24 months.