A trial looking at treating depression in people with cancer (SMaRT Oncology 2)

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. We know from research that having depression along with a medical condition can really affect quality of life. And people with depression may be less likely to stick to their treatment plan.

Although depression is common in people who have cancer, it may not always be noticed. Yet it can be one of the hardest things to cope with. We are now getting better at recognising and treating depression in people with cancer. But there is still a lot more research to be done.

This trial will compare 2 ways of treating depression in people with cancer. People taking part have either

The usual care from your family doctor or cancer specialist
The usual care, with extra treatment from a specially trained nurse

In an earlier trial called SMaRT Oncology 1, this extra treatment helped people with depression more than usual care alone. The aims of this second, much larger trial are to again test how well this treatment works. And to balance this against how much it would cost, to see if this treatment would be ‘cost-effective’ to use in routine care in the future.

You may not have any direct benefit from taking part in this trial. But the results may be used to help people with cancer in the future.

Recruitment

Start 01/05/2008

End 27/05/2011

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 Greater Glasgow and Clyde, NHS Fife, NHS Forth Valley, NHS Lanarkshire or NHS Tayside and you

Have been diagnosed with cancer
Have had symptoms of major depression for at least a month, and these have been picked up at your clinic
Are able to come to hospital for treatment sessions
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 500 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 the 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 6 to 8 sessions. Your nurse will talk with you about how to cope with depression and what might help you to feel better. Each session will be video recorded so that the trial team can make sure that everyone’s treatment is of the same high standard. After this first course of treatment you will have a phone call once a month for about a year from your nurse.

Everyone taking part will also fill out short questionnaires every 3 months for a year. These should take about 10 minutes to complete, and will ask about how you feel physically and emotionally. The questionnaires are sent and returned by post. The trial team may phone you to ask more about some of your answers.

You will continue to see your regular cancer team during and after the trial.

Hospital visits

If you are in group 2, you will visit the hospital about 6 to 8 times over 16 weeks to see the trial nurse. These meetings will take between 30 and 45 minutes.