NYU-Langone Health and NYU Perlmutter Cancer Center, New York, NY, United States of America; Manhattan Veteran Affairs, New York, NY, United States of America.
Fred Hutchinson Cancer Center, University of Washington, Seattle, WA, United States of America.
Contemp Clin Trials. 2022 Aug;119:106821. doi: 10.1016/j.cct.2022.106821. Epub 2022 Jun 14.
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.
种系检测在前列腺癌治疗中具有越来越重要的作用。然而，遗传咨询师相对短缺，这就需要采取替代策略来提供种系检测前的教育。这项由前列腺癌基金会资助的研究旨在解决种系检测前教育的新的传递方法的需求，超越传统的种系咨询，以促进种系检测的知情患者决策。
这是一项两臂随机对照试验（RCT），每个研究臂的目标入组人数为 173 名患有前列腺癌的患者（总预期入组人数为 346 名）。根据肿瘤特征、家族史或阿什肯纳兹犹太人血统，从美国的 5 个地点（包括学术、私人诊所和退伍军人医疗保健机构）招募符合种系检测标准的患者。同意参与的患者被随机分配到互动式预测试网络工具或种系咨询组，评估与种系检测知情决策相关的关键患者报告结果。
参与者在基线、预测试教育/咨询后以及种系结果披露后完成调查。该研究的主要结果是种系检测的决策冲突。次要结果包括遗传知识、满意度、种系检测的接受率以及对结果的理解。
我们的假设是，基于网络的遗传教育工具在种系检测知情决策的关键患者报告结果方面不劣于传统的遗传咨询。如果得到证实，结果将支持在各种实践环境中部署网络工具，以促进前列腺癌患者的预测试遗传教育，并制定与遗传咨询合作的护理策略。
gov 标识符：NCT04447703。
