Walker Jane, Cassidy Jim, Sharpe Michael
University of Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, Scotland, UK.
Trials. 2009 Mar 30;10:18. doi: 10.1186/1745-6215-10-18.
Depression Care for People with 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. In a 'proof of concept' trial (Symptom Management Research Trials in Oncology-1) Depression Care for People with Cancer improved depression more than usual care alone. The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2 Trial) will test its effectiveness and cost-effectiveness in a 'real world' setting.
A two arm parallel group multi-centre randomised controlled trial. TRIAL PROCEDURES: 500 patients will be recruited through established systematic Symptom Monitoring Services, which screen patients for depression. Patients will have: a diagnosis of cancer (of various types); an estimated life expectancy of twelve 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 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 'treatment response' measured at 24 week outcome data collection. 'Treatment response' will be defined as a reduction of 50% or more in the patient's baseline depression score, measured using the 20-item Symptom Checklist (SCL-20D). Secondary outcomes include remission of major depressive disorder, depression severity and patients' self-rated improvement of depression.
Current controlled trials ISRCTN40568538 TRIAL HYPOTHESES: (1) Depression Care for People with Cancer as a supplement to usual care will be more effective than usual care alone in achieving a 50% reduction in baseline SCL-20D score at 24 weeks. (2) Depression Care for People with Cancer as a supplement to usual care will cost more than usual care alone but will be more cost effective in achieving improvements in patients' depression and quality of life.
癌症患者抑郁护理是一种由经过专门培训的癌症护士在精神科医生监督下实施的复杂干预措施。它作为对患者从全科医生和癌症服务机构获得的常规抑郁护理的补充。在一项“概念验证”试验（肿瘤学症状管理研究试验-1）中，癌症患者抑郁护理比单纯的常规护理更能改善抑郁症状。第二项肿瘤学症状管理研究试验（SMaRT肿瘤学-2试验）将在“现实世界”环境中测试其有效性和成本效益。
双臂平行组多中心随机对照试验。
将通过已建立的系统症状监测服务招募500名患者，该服务对患者进行抑郁筛查。患者需具备：癌症诊断（各种类型）；预计生存期为十二个月或更长时间以及重度抑郁症诊断。患者将被随机分为接受常规护理或常规护理加癌症患者抑郁护理。随机分组将通过拨打安全的计算机化中央随机系统或使用安全的网络界面进行。主要结局指标是在24周结局数据收集时测量的“治疗反应”。“治疗反应”将定义为使用20项症状清单（SCL-20D）测量的患者基线抑郁评分降低50%或更多。次要结局包括重度抑郁症的缓解、抑郁严重程度以及患者自评的抑郁改善情况。
当前对照试验ISRCTN40568538
（1）癌症患者抑郁护理作为常规护理的补充，在24周时使基线SCL-20D评分降低50%方面比单纯常规护理更有效。（2）癌症患者抑郁护理作为常规护理的补充，成本将高于单纯常规护理，但在改善患者抑郁和生活质量方面更具成本效益。
