• Jane Walker, Jim Cassidy, Michael Sharpe, and SMaRT Oncology-3 Trialists.
• Cancer Research UK, The University of Edinburgh Cancer Research Centre, Western General Hospital, Crewe Road, Edinburgh, UK. jane.walker@ed.ac.uk
• Trials. 2009 Jan 1;10:92.

BackgroundDepression Care for People with Lung Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3 Trial) will test its efficacy when compared to usual care alone.DesignA two arm parallel group multi-centre randomised controlled trial. 200 patients will be recruited through established systematic Symptom Monitoring Services, which screen patients for depression. Patients will have: a diagnosis of lung cancer; an estimated life expectancy of three months or more and a diagnosis of Major Depressive Disorder. Patients will be randomised to usual care or usual care plus Depression Care for People with Lung Cancer. Randomisation will be carried out by telephoning a secure computerised central randomisation system or by using a secure web interface. The primary outcome measure is average depression severity. This will be assessed using scores on the 20-item Symptom Hopkins Checklist (SCL-20D), collected every four weeks over 32 weeks. Secondary outcomes include severity of anxiety, pain and fatigue; self-rated improvement of depression; quality of life and satisfaction with depression care.Trial RegistrationCurrent controlled trials ISRCTN75905964.

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