背景:遗传性肿瘤风险综合征在欧洲每年诊断的400万例癌症中至少占5%至10%。目前,肿瘤患者的护理缺乏医学遗传学专家,农村地区缺乏遗传护理以及肿瘤学家和医学遗传学家之间的结构化护理途径。因此,遗传性肿瘤风险综合征未被诊断,对患者及其家属有潜在的致命后果.
方法:OnkoRiskNET研究得到德意志联邦共和国联邦联合委员会的资助。该研究将包括2021年7月研究开始后来自下萨克森州和萨克森州肿瘤学实践的2,000名肿瘤指数患者。在实践水平上通过阶梯式楔形设计进行随机化。患者要么通过常规护理,要么通过医学遗传学家和肿瘤学家之间的结构化合作进行新的护理形式,病例管理和远程医疗遗传咨询的使用。使用混合方法方法,将在对照和干预组中评估以下参数:(1)由疑似肿瘤风险综合征患者及其一级亲属进行遗传咨询会议;(2)遗传咨询和测试后的患者满意度和心理困扰;(3)影响远程医学遗传咨询的接受度和经验的因素;(4)肿瘤学家和医学遗传学对结构化途径的满意度;(5)新形式护理的成本效益。
结论:OnkoRiskNET旨在通过在执业肿瘤学家和医学遗传学专家之间形成合作网络以及使用远程医学遗传咨询来缩小护理差距,因此,提高遗传性肿瘤风险综合征的诊断率,并作为德国未来遗传护理的典范。
背景:试验于01.12.2021在德国临床试验注册(https://trialsearch。谁。int/)与DRKS-ID:DRKS00026679。
背景:合作网络为患有遗传性肿瘤风险综合征的患者和家庭提供当地护理。试验首字母缩写:OnkoRiskNET。协议版本1.1。
BACKGROUND: Genetic tumor risk syndromes are responsible for at least five to ten percent of the 4 million cases of cancer diagnosed in Europe every year. Currently, the care of oncological patients suffers from a lack of specialists in medical genetics and also a lack of access to genetic care in rural areas and structured care pathways between oncologists and medical geneticists. As a result, genetic tumor risk syndromes are underdiagnosed with potentially fatal consequences for patients and their families.
METHODS: The OnkoRiskNET study is supported by a grant from the Federal Joint Committee of the Federal Republic of Germany. The study will include 2,000 oncological index patients from oncology practices in Lower Saxony and Saxony after the start of the study in July 2021. Randomization is carried out by means of a stepped wedge design at the level of the practices. Patients either go through routine care or the new form of care with structured cooperation between medical geneticists and oncologists, case management and the use of telemedical genetic counseling. Using a mixed-methods approach, the following parameters will be evaluated in the control and intervention group: (1) Conducted genetic counseling sessions by patients with suspected tumor risk syndrome and their first degree relatives; (2) Patient satisfaction and psychological distress after genetic counseling and testing; (3) Factors influencing the acceptance and experience of telemedical genetic counseling; (4) Satisfaction of oncologists and medical genetics with the structured pathway; (5) Cost efficiency of the new form of care.
CONCLUSIONS: OnkoRiskNET aims to close the gap in care through the formation of a cooperation network between practicing oncologists and specialists in medical genetics and the use of telemedical genetic counseling, thereby, increasing the diagnostic rate in genetic tumor risk syndromes and serving as a model for future genetic care in Germany.
BACKGROUND: Trial was registered on 01.12.2021 in the German Clinical Trial Register ( https://trialsearch.who.int/ ) with the DRKS-ID: DRKS00026679 .
BACKGROUND: Cooperation network for the provision of local care for patients and families with a genetic tumour risk syndrome. Trial acronym: OnkoRiskNET. Protocol version 1.1.