结构化心理肿瘤筛查与治疗模式对癌症患者心理健康的影响（逐步护理）：一项整群随机对照试验的研究方案
Effect of a structured psycho-oncological screening and treatment model on mental health in cancer patients (STEPPED CARE): study protocol for a cluster randomized controlled trial.
作者信息
Singer Susanne, Danker Helge, Briest Susanne, Dietrich Arne, Dietz Andreas, Einenkel Jens, Papsdorf Kirsten, Lordick Florian, Meixensberger Jürgen, Mössner Joachim, Niederwieser Dietger, Prietzel Torsten, Schiefke Franziska, Stolzenburg Jens-Uwe, Wirtz Hubert, Kersting Anette
机构信息
Institute of Medical Biostatistics, Epidemiology, and Informatics (IMBEI), Division of Epidemiology and Health Services Research, University Medical Center Mainz, Obere Zahlbacher Straße 69, 55131 Mainz, Germany.
出版信息
Trials. 2014 Dec 10;15:482. doi: 10.1186/1745-6215-15-482.
BACKGROUND
High levels of emotional distress in cancer patients often goes unnoticed in daily clinical routine, resulting in severe undertreatment of mental health problems in this patient group. Screening tools can be used to increase case identification, however, screening alone does not necessarily translate into better mental health for the patient. Doctors play a key role in providing basic emotional support and transferring the patients in need of such specific support to mental health professionals. This study investigates whether a stepped care model, combining screening, doctor consultation and professional psycho-oncological service in a structured way, improves the emotional wellbeing of cancer patients.
METHODS/DESIGN: This study is a cluster randomized trial with two parallel groups (intervention vs. care as usual), set in an academic hospital. Participants are cancer patients, a total of 1,000 at baseline. The intervention consists of stepped psychosocial care. Step one: screening for distress, step two: feedback of screening results to the doctor in charge of the patient and consultation with the patient, and step three: based on a shared patient-doctor decision, either transferal to the consultation liaison (CL) service or not. The outcome will be emotional well-being half a year after baseline, ascertained with the Hospital Anxiety and Depression Scale. Randomization will be done by the cluster randomization of wards.
DISCUSSION
Mental health problems not only cause emotional suffering but also direct and indirect costs. This calls for timely and adequate psychosocial support, especially as we know that such support is effective. However, not every cancer patient can and must be treated by a mental health professional. Allocating limited resources most sensibly and economically is of crucial importance for our healthcare system to ensure the best quality of care to as many patients as possible. It is the hope of the STEPPED CARE trial that this model is both effective and efficient, and that it can be implemented in other hospitals as well, if proven to be effective.
TRIAL REGISTRATION
Clinical Trials Register (Clinicaltrials.gov) identifier: NCT01859429 registration date 17 May 2013.
背景
癌症患者的高度情绪困扰在日常临床工作中常常被忽视，导致该患者群体的心理健康问题严重治疗不足。筛查工具可用于增加病例识别，然而，仅筛查并不一定能为患者带来更好的心理健康。医生在提供基本情感支持以及将需要此类特殊支持的患者转介给心理健康专业人员方面发挥着关键作用。本研究调查了一种阶梯式护理模式，即以结构化方式结合筛查、医生咨询和专业心理肿瘤学服务，是否能改善癌症患者的情绪健康。
方法/设计：本研究是一项在学术医院进行的整群随机试验，有两个平行组（干预组与常规护理组）。参与者为癌症患者，基线时共有1000名。干预措施包括阶梯式心理社会护理。第一步：进行痛苦筛查；第二步：将筛查结果反馈给负责该患者的医生并与患者进行咨询；第三步：根据医患共同决策，决定是否转介至会诊联络（CL）服务。结局指标将是基线后半年的情绪健康状况，通过医院焦虑抑郁量表确定。随机分组将通过病房整群随机进行。
讨论
心理健康问题不仅会造成情感痛苦，还会产生直接和间接成本。这就需要及时提供充分的心理社会支持，特别是因为我们知道这种支持是有效的。然而，并非每个癌症患者都能且必须由心理健康专业人员进行治疗。合理且经济地分配有限资源对于我们的医疗系统至关重要，以确保尽可能多的患者获得最佳护理质量。阶梯式护理试验希望该模式既有效又高效，并且如果被证明有效，也能在其他医院实施。
试验注册
临床试验注册库（Clinicaltrials.gov）标识符：NCT01859429，注册日期2013年5月17日。
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