结直肠癌患者的跨部门护理：随机对照多中心试验“支持性癌症护理网络工作者（SCAN）”方案
Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN).
作者信息
Bauer Alexander, Vordermark Dirk, Seufferlein Thomas, Schmoll Hans-Joachim, Dralle Henning, Mau Wilfried, Unverzagt Susanne, Boese Stephanie, Fach Eva-Maria, Landenberger Margarete
机构信息
Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science, Magdeburger Strasse 8, D-06112, Halle, Germany.
Department of Radiation Oncology, University Hospital Halle, Ernst-Grube-Strasse 40, D-06120, Halle, Germany.
出版信息
BMC Cancer. 2015 Dec 22;15:997. doi: 10.1186/s12885-015-2002-6.
BACKGROUND
Managing therapy-related side-effects and improving health-related quality of life in patients with colorectal cancer is still challenging. The need for an effective management of adverse events and unmet supportive care needs have been widely discussed. In the past decade, interventions by nursing staff gained more and more importance. Evidence suggests that a majority of patients even in early stages of the disease experience substantial impairments potentially resulting in diminished therapy adherence as well as impaired quality of life. However, evidence for the effectiveness of nurse-led interventions on symptom management and quality of life is still very limited. This especially applies to care transitions between different inpatient and outpatient health care providers throughout the course of treatment and aftercare.
METHODS/DESIGN: Supportive Cancer Care Networkers (SCAN) is a prospective randomized controlled trial conducted in eight large and middle-sized German cancer centers and municipal hospitals. The target population is adults with colorectal cancer UICC I-III after initial R-0 resection scheduled for adjuvant chemotherapy or guideline-based aftercare only. 370 patients will be randomly assigned to either intervention or control group. Patients in the intervention group will receive an additional support by specialized oncology nurses for eight weeks after discharge from hospital by telephone, consisting of symptom monitoring, counselling on self-assessment and self-management and dealing with individual resources for coping and psychosocial well-being. The primary endpoint will be health-related quality of life (HRQoL) at eight weeks after discharge from the initial treating hospital.
DISCUSSION
The presented SCAN trial is to provide information that will be useful to advance our understanding of complex interdependencies between symptom severity, supportive care needs, functioning and the risk for diminished HRQoL. Most importantly, these patient-reported outcomes are not fully implemented in today's clinical routine practice potentially resulting in therapy cessations and lower chemotherapy treatment rates for colorectal cancer especially in older patients.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT01651832.
背景
对结直肠癌患者进行与治疗相关的副作用管理并改善其健康相关生活质量仍然具有挑战性。对不良事件进行有效管理以及满足未得到满足的支持性护理需求的必要性已得到广泛讨论。在过去十年中，护理人员的干预变得越来越重要。有证据表明，即使是处于疾病早期阶段的大多数患者也会经历严重的损害，这可能导致治疗依从性下降以及生活质量受损。然而，关于护士主导的干预措施对症状管理和生活质量有效性的证据仍然非常有限。这尤其适用于整个治疗过程和后续护理中不同住院和门诊医疗服务提供者之间的护理过渡。
方法/设计：支持性癌症护理网络者（SCAN）是一项在德国八个大中型癌症中心和市立医院进行的前瞻性随机对照试验。目标人群是计划接受辅助化疗或仅接受基于指南的后续护理的 UICC I - III 期结直肠癌成年患者，这些患者在初次 R - 0 切除术后。370 名患者将被随机分配到干预组或对照组。干预组的患者在出院后八周将通过电话接受专业肿瘤护士的额外支持，包括症状监测、自我评估和自我管理咨询以及应对个人应对资源和心理社会福祉。主要终点将是从初始治疗医院出院八周后的健康相关生活质量（HRQoL）。
讨论
所呈现的 SCAN 试验旨在提供信息，有助于增进我们对症状严重程度、支持性护理需求、功能以及 HRQoL 下降风险之间复杂相互依存关系的理解。最重要的是，这些患者报告的结果在当今的临床常规实践中并未得到充分实施，这可能导致结直肠癌尤其是老年患者的治疗中断和较低的化疗治疗率。
试验注册
ClinicalTrials.gov 标识符 NCT01651832。
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