Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC (GWH, K-GL, TD, BNP, CF, MDS)
Section of Genetics and Metabolism, Albany Medical Center, Albany, NY (EW)
Med Decis Making. 2011 May-Jun;31(3):412-21. doi: 10.1177/0272989X10381283. Epub 2010 Sep 27.
Increasingly, women with a strong family history of breast cancer are seeking genetic testing as a starting point to making significant decisions regarding management of their cancer risks. Individuals who are found to be carriers of a BRCA1 or BRCA2 mutation have a substantially elevated risk for breast cancer and are frequently faced with the decision of whether to undergo risk-reducing mastectomy.
In order to provide BRCA1/2 carriers with ongoing decision support for breast cancer risk management, a computer-based interactive decision aid was developed and tested against usual care in a randomized controlled trial.
. Following genetic counseling, 214 female (aged 21-75 years) BRCA1/2 mutation carriers were randomized to usual care (UC; n = 114) or usual care plus decision aid (DA; n = 100) arms. UC participants received no further intervention; DA participants were sent the CD-ROM-based decision aid to view at home.
The authors measured general distress, cancer-specific distress, and genetic testing-specific distress at 1-, 6-, and 12-month follow-up time points postrandomization.
Longitudinal analyses revealed a significant longitudinal impact of the DA on cancer-specific distress (B = 5.67, z = 2.81, P = 0.005), which varied over time (DA group by time; B = -2.19, z = -2.47, P = 0.01), and on genetic testing-specific distress (B = 5.55, z = 2.46, P = 0.01), which also varied over time (DA group by time; B = -2.46, z = -2.51, P = 0.01). Individuals randomized to UC reported significantly decreased distress in the month following randomization, whereas individuals randomized to the DA maintained their postdisclosure distress over the short term. By 12 months, the overall decrease in distress between the 2 groups was similar.
This report provides new insight into the long-term longitudinal effects of DAs.
越来越多的乳腺癌高危家族史女性选择进行基因检测，作为管理癌症风险的起点。携带 BRCA1 或 BRCA2 突变的个体乳腺癌发病风险显著增加，她们经常面临是否接受预防性乳房切除术的决策。
为了为 BRCA1/2 携带者提供持续的乳腺癌风险管理决策支持，我们开发了一种基于计算机的交互式决策辅助工具，并在一项随机对照试验中对其进行了与常规护理的比较。
在遗传咨询后，214 名（年龄 21-75 岁）BRCA1/2 突变携带者被随机分为常规护理（UC；n = 114）或常规护理加决策辅助（DA；n = 100）组。UC 组不接受进一步干预；DA 组参与者收到基于 CD-ROM 的决策辅助工具在家中查看。
作者在随机分组后 1、6 和 12 个月的随访时间点测量一般困扰、癌症特异性困扰和基因检测特异性困扰。
纵向分析显示，DA 对癌症特异性困扰（B = 5.67，z = 2.81，P = 0.005）有显著的纵向影响，且该影响随时间变化（DA 组与时间；B = -2.19，z = -2.47，P = 0.01），对基因检测特异性困扰（B = 5.55，z = 2.46，P = 0.01）也有显著的纵向影响，且该影响随时间变化（DA 组与时间；B = -2.46，z = -2.51，P = 0.01）。随机分配到 UC 组的个体在随机分组后的一个月内报告的困扰显著减少，而随机分配到 DA 组的个体在短期内保持了披露后的困扰。到 12 个月时，两组之间的总体困扰下降相似。
本报告提供了有关决策辅助工具长期纵向影响的新见解。
