Porzig Ralf, Neugebauer Sina, Heckmann Thomas, Adolf Daniela, Kaskel Peter, Froster Ursula G
"Onkolotse" Cancer Patient Navigation Project, Sächsische Krebsgesellschaft e.V, Schlobigplatz 23, 08056, Zwickau, Germany.
MSD SHARP & DOHME GMBH, Lindenplatz 1, 85540, Haar, Germany.
BMC Health Serv Res. 2018 Jun 5;18(1):413. doi: 10.1186/s12913-018-3226-3.
Concepts for the nursing and care of cancer patients through a "navigation service" have attracted much interest. However, there is still room for improvement in terms of their funding and coverage. The Saxon Cancer Society designed a prospective, randomized, multicenter, longitudinal study with a view to determining the positive effects of a cancer patient navigator program. The objective of this ongoing study is to evaluate the impact of the cancer patient navigation program on cancer patients and cost bearers in Germany.
The study population in this evaluation comprises cancer patients with gastric carcinoma, pancreatic carcinoma, colorectal cancer, melanoma or gynecological cancer who have been hospitalized at least once at one of the study centers as well as their relatives, outpatient and inpatient physicians, and cancer nurses. It is planned to randomize 340 cancer patients (stomach, colonic/rectal cancer, gynecological cancer, melanoma) at five centers to an intervention group (care by patient navigators based on standardized operating procedures) or a control group in a one-to-one ratio. The primary target parameter is the number of hospitalizations within the 12-month intervention period. The participants are asked to complete various questionnaires on patient-related outcomes at baseline and at 3 and 12 months (SF 36, HADS, PAM 13, and others). Data on drug therapy, utilization of health services, and medical expenses will also be analyzed.
For the first time, the study will provide data on the effectiveness of a patient support program in cancer care in Germany from a randomized trial with a high level of evidence.
The study has been registered under DRKS00013199 in the German Clinical Trials Register.
通过“导航服务”对癌症患者进行护理的理念引起了广泛关注。然而，在资金和覆盖范围方面仍有改进空间。萨克森癌症协会设计了一项前瞻性、随机、多中心、纵向研究，旨在确定癌症患者导航计划的积极效果。这项正在进行的研究的目的是评估癌症患者导航计划对德国癌症患者和费用承担者的影响。
本评估中的研究人群包括患有胃癌、胰腺癌、结直肠癌、黑色素瘤或妇科癌症的癌症患者，他们至少在其中一个研究中心住院过一次，以及他们的亲属、门诊和住院医生，还有癌症护士。计划在五个中心将340名癌症患者（胃癌、结肠癌/直肠癌、妇科癌症、黑色素瘤）以一对一的比例随机分为干预组（由患者导航员根据标准化操作程序进行护理）或对照组。主要目标参数是干预期12个月内的住院次数。要求参与者在基线以及3个月和12个月时完成各种关于患者相关结局的问卷（SF 36、HADS、PAM 13等）。还将分析药物治疗、卫生服务利用和医疗费用的数据。
该研究将首次通过一项具有高度证据水平的随机试验，提供关于德国癌症护理中患者支持计划有效性的数据。
该研究已在德国临床试验注册中心以DRKS00013199进行注册。
