A trial looking at treating depression in people with lung cancer (SMaRT Oncology 3)

Please note this trial is no longer recruiting patients.

This trial is looking at adding sessions with a specially trained cancer nurse to the routine treatment for depression. If you have cancer, it is not unusual to have symptoms of stress. But sometimes these symptoms are severe and may be called depression.

Depression is a major problem for people with lung cancer. A large survey of people with cancer found that the thoughts and feelings of those with lung cancer were affected more than people with other types of cancer (they had the highest level of ‘psychological distress’). Doctors want to offer more support to people with lung cancer who have depression. But at the moment they are unsure of the best way to do this.

Researchers have already developed a treatment for depression in people with cancer, involving extra regular support from a specially trained nurse. An earlier trial (SMaRT Oncology 1) showed that those who had this treatment coped better than those who did not. Researchers have since altered the treatment to suit the needs of people with lung cancer.

This trial will test this altered treatment by comparing it with the usual care you would have from your family doctor or cancer specialist. The main aim of the trial is to see how much this extra treatment helps people compared to standard treatment alone.

Recruitment

Start 05/01/2009

End 09/09/2011

Phase

Other

Who can enter

You can enter this trial if you are a patient under the care of a specialist cancer clinic that is part of NHS Lothian NHS Fife, NHS Forth Valley, NHS Lanarkshire, NHS Tayside or NHS Greater Glasgow and Clyde, and you

Have lung cancer
Have had symptoms of major depression for at least a month, and these have been picked up at your clinic
Are at least 18 years old

You cannot enter this trial if you

Have had continuous depression for 2 years or more
Need urgent care from a specialist mental health team (psychiatric care)
Are already seeing a specialist from the mental health team (psychiatrist or psychologist)
Have difficulty learning, understanding and remembering information (cognitive impairment), or find it difficult to understand written or spoken English
Have cancer that has spread to your brain

Trial design

This trial will recruit 200 people. It is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have the routine care for your symptoms of depression. Your cancer specialist or family doctor will decide the best treatment plan for you. This may mean letting these symptoms take their course. Or they may offer you antidepressant medication, or refer you to a counsellor.

If you are in group 2, as well as having routine care, you will meet with a specially trained nurse for about 6 to 8 sessions. Your nurse will talk with you about how to cope with depression and what might help you to feel better. With your permission, each session will be video recorded, so that the trial team can make sure everyone’s treatment is of the same high standard.

The trial team may also phone you once to find out what you thought about this treatment. This call will take about 20 minutes.

Everyone taking part will also complete a questionnaire over the phone once a month for 8 months. A member of the trial team will phone you to do this. They will ask you about how you are feeling physically and emotionally. It will take about 20 minutes.

Hospital visits

If you are in group 2, you will see the trial nurse between 6 and 8 times during the trial. You will go to hospital for these meetings. If you do not feel well enough to travel to the hospital, the nurse will come to you instead. The meetings will take between 30 to 45 minutes.