The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3): a randomised trial to determine the efficacy of adding a complex intervention for major depressive disorder (<it>Depression Care for People with Lung Cancer</it>) to usual care, compared to usual care alone in patients with lung cancer

• Main Authors: Sharpe Michael, Cassidy Jim, Walker Jane
• Format: Article
• Language: English
• Published: BMC 2009-09-01
• Series: Trials
• Online Access: http://www.trialsjournal.com/content/10/1/92

<p>Abstract</p> <p>Background</p> <p><it>Depression Care for People with Lung Cancer </it>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.</p> <p>Design</p> <p>A 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 <it>Depression Care for People with Lung Cancer</it>. 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.</p> <p>Trial Registration</p> <p>Current controlled trials ISRCTN75905964</p>