胚系测试在前列腺癌护理中具有越来越重要的作用。然而,遗传咨询师的相对短缺需要替代策略来提供种系测试的测试前教育。这项研究,由前列腺癌基金会资助,旨在解决在传统种系咨询之外提供测试前种系教育的新方法的需求,以促进患者对种系测试的知情决策。
这是一项双臂随机对照试验(RCT),每个研究小组目标招募173名前列腺癌参与者(总预期n=346)。符合基于肿瘤特征的种系检测标准的患者,家族史或阿什肯纳齐犹太血统正在从5个美国网站招募,包括学术,私人诊所和退伍军人医疗机构。同意的参与者被随机分配到交互式预测试webtool或生殖系咨询,评估涉及生殖系测试的知情决策的关键患者报告结果。
参与者在基线时完成调查,在测试前教育/咨询之后,以及种系结果的披露。该研究的主要结果是种系测试的决定性冲突。次要结果包括遗传知识,满意,种系测试的摄取,以及对结果的理解。
我们的假设是,基于网络的遗传教育工具在涉及生殖系测试的知情决策的关键患者报告结果方面不劣于传统遗传咨询。如果证明,结果将支持在各种实践环境中部署webtool,以促进前列腺癌患者的测试前遗传教育,并与遗传咨询一起制定协作护理策略.
gov标识符:NCT04447703。
Germline testing has an increasingly important role in prostate cancer care. However, a relative shortage of genetic counselors necessitates alternate strategies for delivery of pre-test education for germline testing. This
study, funded by the Prostate Cancer Foundation, seeks to address the need for novel methods of delivery of pre-test germline education beyond traditional germline counseling to facilitate informed patient decision-making for germline testing.
This is a two-armed randomized controlled
trial (RCT) with a target enrollment of 173 participants with prostate cancer per
study arm (total anticipated n = 346). Patients who meet criteria for germline testing based on tumor features, family history or Ashkenazi Jewish ancestry are being recruited from 5 US sites including academic, private practice and Veterans healthcare settings. Consenting participants are randomized to the interactive pretest webtool or germline counseling with assessment of key patient-reported outcomes involved in informed decision-making for germline testing.
Participants complete surveys at baseline, after pretest education/counseling, and following disclosure of germline results. The primary outcome of the
study is decisional conflict for germline testing. Secondary outcomes include genetic knowledge, satisfaction, uptake of germline testing, and understanding of results.
Our hypothesis is that the web-based genetic education tool is non-inferior to traditional genetic counseling regarding key patient-reported outcomes involved in informed decision-making for germline testing. If proven, the results would support deploying the webtool across various practice settings to facilitate pre-test genetic education for individuals with prostate cancer and developing collaborative care strategies with genetic counseling.
gov Identifier: NCT04447703.