The FamilyTalk randomized controlled trial: patient-reported outcomes in clinical genetic sequencing for colorectal cancer.
The FamilyTalk randomized controlled trial: patient-reported outcomes in clinical genetic sequencing for colorectal cancer.
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FamilyTalk 随机对照试验：患者报告的结直肠癌临床基因测序结果。
DOI：
10.1007/s10552-021-01398-1
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发表时间：
2021
期刊：
影响因子：
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通讯作者：
Jarvik,GailP
中科院分区：
文献类型：
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作者：
Makhnoon,Sukh;Bowen,DeborahJ;Shirts,BrianH;Fullerton,StephanieM;Larson,EricB;Ralston,JamesD;Leppig,KathleenA;Crosslin,DavidR;Veenstra,David;Jarvik,GailP
随着遗传学在临床肿瘤学中获得青睐，解决患者对遗传信息的保密性、隐私和安全性的担忧是重要的，否则可能会限制其使用。我们设计了一项随机对照试验来评估在线教育工具(FamilyTalk)的社会影响，以增加关于结直肠癌(CRC)风险和筛查的家庭沟通。在208名随机调查的参与者中，149人(71.6%)返回了六个月的调查。总体而言，两组研究人员在结直肠癌筛查方面没有差异。对医疗和基因信息的隐私和保密担忧，对基因测试结果的反应，以及生活方式的改变，在不同的军队中没有不同之处。具有致病或可能致病(P/LP)结果和变异的不确定意义(VUS)结果的参与者比那些阴性结果的参与者更有可能报告结果准确地预测了他们的疾病风险(OR5.37，p= 0.02和OR3.13，p= 0.02)。这项试验没有证据表明FamilyTalk影响了患者报告的结果。由于总体样本中有P/LP结果的参与者数量有限，以及随访期短，能量低可能是导致无效结果的原因之一。
As genetics gains favor in clinical oncology, it is important to address patient concerns around confidentiality, privacy, and security of genetic information that might otherwise limit its utilization. We designed a randomized controlled trial to assess the social impact of an online educational tool (FamilyTalk) to increase family communication about colorectal cancer (CRC) risk and screening. Of 208 randomized participants, 149 (71.6%) returned six-month surveys. Overall, there was no difference in CRC screening between the study arms. Privacy and confidentiality concerns about medical and genetic information, reactions to genetic test results, and lifestyle changes did not differ between arms. Participants with pathogenic or likely pathogenic (P/LP) and variant of uncertain significance (VUS) results were more likely than those with negative results to report that the results accurately predicted their disease risks (OR 5.37,p= 0.02 and OR 3.13,p= 0.02, respectively). This trial demonstrated no evidence that FamilyTalk impacted patient-reported outcomes. Low power, due to the limited number of participants with P/LP results in the overall sample, as well as the short follow-up period, could have contributed to the null findings.