是否需要强制遗传咨询?

IF 503.1 1区 医学 Q1 ONCOLOGY CA: A Cancer Journal for Clinicians Pub Date : 2024-03-13 DOI:10.3322/caac.21831
Mike Fillon
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According to the lead study author, Elizabeth Swisher, MD, a professor in the Department of Obstetrics and Gynecology and coleader of the Breast and Ovarian Cancer Research Program at the Fred Hutchinson/University of Washington Cancer Consortium in Seattle, Washington, the investigation sought to establish if skipping the standard counseling increased posttest distress and whether that would affect completing the testing process.</p><p>According to Dr Swisher, the researchers believe that MAGENTA is the first large randomized clinical trial evaluating the effect of individualized preand posttest counseling for cancer risk assessment while providing electronic enrollment, remote testing, and counseling. “As a result, we hoped to identify more accessible options for patients to get cancer genetic risk assessments without negatively impacting their worries about cancer risk.”</p><p>Study participants in all of the cohorts were found through social media and advertisements in traditional media outlets. All were enrolled between April 27, 2017, and September 29, 2020. The data analysis was performed between December 13, 2020, and May 31, 2023.</p><p>Participants were limited to English-speaking female residents of the United States who were at least 30 years old and had a family or personal history of breast or ovarian cancer. Each had to have internet access and access to a licensed health care professional. Those who had previously undergone genetic counseling were not eligible. There was no financial incentive offered.</p><p>The participants were assigned to either a family history cohort or a familial pathogenic variant (PV) cohort. The family history cohort included participants with a personal or family history of breast or ovarian cancer. To qualify for the PV cohort, participants needed a minimum of one biological relative with a PV in <i>BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1,</i> or <i>PMS2</i>. There were 3125 in the family history cohort and 714 in the familial PV cohort.</p><p>The participants then watched a video about genetic testing, signed consent forms, and completed baseline questionnaires. Genetic counseling was provided by phone appointments, and testing was performed with home-delivered saliva kits. There were follow-up questionnaires at 3 and 12 months.</p><p>The researchers measured each subject’s cancer risk distress by using the Impact of Event Scale 3 months after genetic testing within the family history cohort; scores ranged from 0 to 75, with high distress indicated by a score of 20 or higher.</p><p>The primary outcome, distress 3 months after genetic testing, was similar in all arms of the study. The rate of high distress did not differ between the various arms of the study at either 3 or 12 months. In the family history cohort, all three experimental arms were noninferior to the control arm for distress at 3 and 12 months.</p><p>Overall, researchers reported high distress levels in 18.4% of the participants at 3 months; this level of distress persisted in 13.8% of the participants at 12 months. The rate of high distress also did not differ between the various arms of the study at either 3 or 12 months.</p><p>As for changes in distress scores from 3 to 12 months (including only those participants who completed both surveys), there was a statistically significant decrease in the mean Impact of Event Scale score from 3 to 12 months. The reduction in distress was significantly larger among those who had a known PV versus those with a family history.</p><p>The completion rates by arm were 76.9% in Arm A, 78.6% in Arm B, 69.2% in Arm C (the control), and 66.4% in Arm D. They also found a 74.1% completion rate in the family history cohort versus 66.8% in the familial PV cohort.</p><p>When it comes to counseling as it relates to genetic testing, Dr Swisher says that patients need options. “Counseling has an incredible value but requiring it when patients aren’t asking for it does not seem necessary. If patients request counseling, however, I think it’s a service we should provide, and if they don’t want counseling, it’s not something we should require.”</p><p>“This is an important study because genetic testing for cancer susceptibility is vastly under-utilized,” says Allison W. Kurian, MD, MSc, a professor of medicine, epidemiology, and population health at the Stanford University School of Medicine in Stanford, California. “This study offered an innovative and successful approach to streamlining the genetic counseling process and should inspire additional work to fine-tune the delivery of cancer genetic testing, Strategies like the ones tested in MAGENTA are essential to help get testing to those who need it.”</p><p>Dr Swisher notes that one of the biggest surprises from the study was the number of patients who went as far as ordering a test kit but never sent it back. She noted that almost 25% of the people who ordered a test kit seemed to change their minds. “Even after we sent them reminders, and even many who said they were at the ‘pulling the trigger’ point, some seemed to have second thoughts. And we found this wasn’t alleviated by pre-test counseling. It was true across the board.”</p><p>In an editorial accompanying the study (doi:10.1001/jamaoncol.2023.3683), Huma Q. Rana, MD, MPH, and Judy E. Garber, MD, MPH, from the Division of Cancer Genetics and Prevention at the Dana-Farber Cancer Institute in Boston, Massachusetts, note that for at least some low-risk patients who tested negative, care models without personalized counseling were noninferior with regard to short-term distress. “This may provide options for testing for individuals who do not have access to genetic counselors.</p><p>“Also notable,” they continued, was that “test completion rates were highest in the 2 arms without any pre-test counseling. However, across arms, decreased test completion was associated with non-Hispanic Black race as well as higher baseline anxiety and higher baseline depression.”</p><p>They added, “Despite significant effort by the investigators, the study population was ultimately homogenous, young, overwhelmingly White, and educated.” They also pointed out that hereditary cancer genetic testing is underutilized in individuals without a cancer diagnosis. “Only 10% of those with history suggestive of hereditary breast and ovarian cancer complete genetic testing.”</p><p>Dr Swisher agrees, saying that a major disappointment was their inability to attract a more diverse population for the study even though they tried different venues, including popular social media channels. “We tried to attract more rural participants, more Blacks and Hispanics. 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The results of Making Genetic Testing Accessible (MAGENTA), a four-armed randomized clinical trial, appear in <i>JAMA Oncology</i> (doi:10.1001/jamaoncol.2023.3748).</p><p>What prompted researchers from the University of Washington to investigate this issue was their recognition that there was low awareness of the necessity of genetic counseling in the testing process. According to the lead study author, Elizabeth Swisher, MD, a professor in the Department of Obstetrics and Gynecology and coleader of the Breast and Ovarian Cancer Research Program at the Fred Hutchinson/University of Washington Cancer Consortium in Seattle, Washington, the investigation sought to establish if skipping the standard counseling increased posttest distress and whether that would affect completing the testing process.</p><p>According to Dr Swisher, the researchers believe that MAGENTA is the first large randomized clinical trial evaluating the effect of individualized preand posttest counseling for cancer risk assessment while providing electronic enrollment, remote testing, and counseling. “As a result, we hoped to identify more accessible options for patients to get cancer genetic risk assessments without negatively impacting their worries about cancer risk.”</p><p>Study participants in all of the cohorts were found through social media and advertisements in traditional media outlets. All were enrolled between April 27, 2017, and September 29, 2020. The data analysis was performed between December 13, 2020, and May 31, 2023.</p><p>Participants were limited to English-speaking female residents of the United States who were at least 30 years old and had a family or personal history of breast or ovarian cancer. Each had to have internet access and access to a licensed health care professional. Those who had previously undergone genetic counseling were not eligible. There was no financial incentive offered.</p><p>The participants were assigned to either a family history cohort or a familial pathogenic variant (PV) cohort. The family history cohort included participants with a personal or family history of breast or ovarian cancer. To qualify for the PV cohort, participants needed a minimum of one biological relative with a PV in <i>BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1,</i> or <i>PMS2</i>. 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引用次数: 0

摘要

随着基因检测越来越多地用于癌症预防和监测,一项新的研究调查了对于有癌症家族史的患者或已知有癌症遗传风险的患者来说,在检测前或检测后跳过咨询是否比要求咨询更糟糕。促使华盛顿大学的研究人员对这一问题进行调查的原因是他们认识到,人们对检测过程中遗传咨询的必要性认识不足。据该研究的主要作者、位于华盛顿州西雅图市的弗雷德-哈钦森/华盛顿大学癌症联合会妇产科教授兼乳腺癌和卵巢癌研究项目联合负责人伊丽莎白-斯韦什尔(Elizabeth Swisher)医学博士介绍,该调查旨在确定跳过标准咨询是否会增加检测后的痛苦,以及这是否会影响检测过程的完成。据 Swisher 博士介绍,研究人员认为,MAGENTA 是首个大型随机临床试验,在提供电子注册、远程测试和咨询的同时,对癌症风险评估的个性化测试前和测试后咨询的效果进行了评估。"因此,我们希望为患者确定更方便的癌症遗传风险评估选择,而不会对他们对癌症风险的担忧产生负面影响。"所有队列中的研究参与者都是通过社交媒体和传统媒体上的广告找到的。所有参与者都是在2017年4月27日至2020年9月29日期间注册的。数据分析在2020年12月13日至2023年5月31日期间进行。参与者仅限于讲英语的美国女性居民,年龄至少在30岁以上,有乳腺癌或卵巢癌家族史或个人史。每个人都必须能上网,并能与有执照的医疗保健专业人员联系。以前接受过遗传咨询的人不符合条件。参与者被分配到家族史队列或家族致病性变异(PV)队列中。家族史队列包括个人或家族有乳腺癌或卵巢癌病史的参与者。要加入 PV 队列,参与者至少需要有一名生物学亲属在 BRCA1、BRCA2、BRIP1、PALB2、RAD51C、RAD51D、BARD1、MSH2、MSH6、MLH1 或 PMS2 中存在 PV。随后,参与者观看了有关基因检测的视频,签署了同意书,并填写了基线问卷。遗传咨询是通过电话预约提供的,检测则是通过送货上门的唾液试剂盒进行的。研究人员在家族史队列中使用 "事件影响量表"(Impact of Event Scale)测量了每位受试者在基因检测 3 个月后的癌症风险困扰程度;得分范围为 0 到 75 分,20 分或更高表示高度困扰。在 3 个月或 12 个月时,各研究组的高度痛苦率没有差异。在家族史队列中,所有三个实验组在 3 个月和 12 个月的痛苦程度上都不优于对照组。总体而言,研究人员报告称,18.4% 的参与者在 3 个月时有较高的痛苦程度;13.8% 的参与者在 12 个月时仍有较高的痛苦程度。至于从 3 个月到 12 个月的痛苦评分变化(仅包括那些完成了两次调查的参与者),从 3 个月到 12 个月,事件影响量表的平均评分出现了统计学意义上的显著下降。他们还发现,家族史队列中的完成率为 74.1%,而家族性 PV 队列中的完成率为 66.8%。Swisher博士说:"咨询具有惊人的价值,但在患者没有提出要求的情况下要求进行咨询似乎没有必要。不过,如果患者要求咨询,我认为这是我们应该提供的服务,如果他们不想要咨询,那就不是我们应该要求的。""这是一项重要的研究,因为癌症易感性基因检测的利用率远远不够,"Allison W. 说。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Is mandated genetic counseling needed?

With genetic testing becoming more readily available for cancer prevention and surveillance, a new study investigated whether skipping counseling—either before or after testing—is any worse than requiring counseling for patients with a family history of cancer or those known to be at genetic risk for cancer. The results of Making Genetic Testing Accessible (MAGENTA), a four-armed randomized clinical trial, appear in JAMA Oncology (doi:10.1001/jamaoncol.2023.3748).

What prompted researchers from the University of Washington to investigate this issue was their recognition that there was low awareness of the necessity of genetic counseling in the testing process. According to the lead study author, Elizabeth Swisher, MD, a professor in the Department of Obstetrics and Gynecology and coleader of the Breast and Ovarian Cancer Research Program at the Fred Hutchinson/University of Washington Cancer Consortium in Seattle, Washington, the investigation sought to establish if skipping the standard counseling increased posttest distress and whether that would affect completing the testing process.

According to Dr Swisher, the researchers believe that MAGENTA is the first large randomized clinical trial evaluating the effect of individualized preand posttest counseling for cancer risk assessment while providing electronic enrollment, remote testing, and counseling. “As a result, we hoped to identify more accessible options for patients to get cancer genetic risk assessments without negatively impacting their worries about cancer risk.”

Study participants in all of the cohorts were found through social media and advertisements in traditional media outlets. All were enrolled between April 27, 2017, and September 29, 2020. The data analysis was performed between December 13, 2020, and May 31, 2023.

Participants were limited to English-speaking female residents of the United States who were at least 30 years old and had a family or personal history of breast or ovarian cancer. Each had to have internet access and access to a licensed health care professional. Those who had previously undergone genetic counseling were not eligible. There was no financial incentive offered.

The participants were assigned to either a family history cohort or a familial pathogenic variant (PV) cohort. The family history cohort included participants with a personal or family history of breast or ovarian cancer. To qualify for the PV cohort, participants needed a minimum of one biological relative with a PV in BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2. There were 3125 in the family history cohort and 714 in the familial PV cohort.

The participants then watched a video about genetic testing, signed consent forms, and completed baseline questionnaires. Genetic counseling was provided by phone appointments, and testing was performed with home-delivered saliva kits. There were follow-up questionnaires at 3 and 12 months.

The researchers measured each subject’s cancer risk distress by using the Impact of Event Scale 3 months after genetic testing within the family history cohort; scores ranged from 0 to 75, with high distress indicated by a score of 20 or higher.

The primary outcome, distress 3 months after genetic testing, was similar in all arms of the study. The rate of high distress did not differ between the various arms of the study at either 3 or 12 months. In the family history cohort, all three experimental arms were noninferior to the control arm for distress at 3 and 12 months.

Overall, researchers reported high distress levels in 18.4% of the participants at 3 months; this level of distress persisted in 13.8% of the participants at 12 months. The rate of high distress also did not differ between the various arms of the study at either 3 or 12 months.

As for changes in distress scores from 3 to 12 months (including only those participants who completed both surveys), there was a statistically significant decrease in the mean Impact of Event Scale score from 3 to 12 months. The reduction in distress was significantly larger among those who had a known PV versus those with a family history.

The completion rates by arm were 76.9% in Arm A, 78.6% in Arm B, 69.2% in Arm C (the control), and 66.4% in Arm D. They also found a 74.1% completion rate in the family history cohort versus 66.8% in the familial PV cohort.

When it comes to counseling as it relates to genetic testing, Dr Swisher says that patients need options. “Counseling has an incredible value but requiring it when patients aren’t asking for it does not seem necessary. If patients request counseling, however, I think it’s a service we should provide, and if they don’t want counseling, it’s not something we should require.”

“This is an important study because genetic testing for cancer susceptibility is vastly under-utilized,” says Allison W. Kurian, MD, MSc, a professor of medicine, epidemiology, and population health at the Stanford University School of Medicine in Stanford, California. “This study offered an innovative and successful approach to streamlining the genetic counseling process and should inspire additional work to fine-tune the delivery of cancer genetic testing, Strategies like the ones tested in MAGENTA are essential to help get testing to those who need it.”

Dr Swisher notes that one of the biggest surprises from the study was the number of patients who went as far as ordering a test kit but never sent it back. She noted that almost 25% of the people who ordered a test kit seemed to change their minds. “Even after we sent them reminders, and even many who said they were at the ‘pulling the trigger’ point, some seemed to have second thoughts. And we found this wasn’t alleviated by pre-test counseling. It was true across the board.”

In an editorial accompanying the study (doi:10.1001/jamaoncol.2023.3683), Huma Q. Rana, MD, MPH, and Judy E. Garber, MD, MPH, from the Division of Cancer Genetics and Prevention at the Dana-Farber Cancer Institute in Boston, Massachusetts, note that for at least some low-risk patients who tested negative, care models without personalized counseling were noninferior with regard to short-term distress. “This may provide options for testing for individuals who do not have access to genetic counselors.

“Also notable,” they continued, was that “test completion rates were highest in the 2 arms without any pre-test counseling. However, across arms, decreased test completion was associated with non-Hispanic Black race as well as higher baseline anxiety and higher baseline depression.”

They added, “Despite significant effort by the investigators, the study population was ultimately homogenous, young, overwhelmingly White, and educated.” They also pointed out that hereditary cancer genetic testing is underutilized in individuals without a cancer diagnosis. “Only 10% of those with history suggestive of hereditary breast and ovarian cancer complete genetic testing.”

Dr Swisher agrees, saying that a major disappointment was their inability to attract a more diverse population for the study even though they tried different venues, including popular social media channels. “We tried to attract more rural participants, more Blacks and Hispanics. There really need to be more community-driven approaches in future studies.”

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来源期刊
CiteScore
873.20
自引率
0.10%
发文量
51
审稿时长
1 months
期刊介绍: CA: A Cancer Journal for Clinicians" has been published by the American Cancer Society since 1950, making it one of the oldest peer-reviewed journals in oncology. It maintains the highest impact factor among all ISI-ranked journals. The journal effectively reaches a broad and diverse audience of health professionals, offering a unique platform to disseminate information on cancer prevention, early detection, various treatment modalities, palliative care, advocacy matters, quality-of-life topics, and more. As the premier journal of the American Cancer Society, it publishes mission-driven content that significantly influences patient care.
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