Li Huanhuan, Zhao Yanjie, Li Wei, Wang Wenxia, Zhi Shengze, Wu Yifan, Zhong Qiqing, Wang Rui, Sun Jiao
School of Nursing, Jilin University, Changchun, Jilin, China.
School of Nursing, Anhui Medical University, Hefei, Anhui, China.
J Med Internet Res. 2025 Apr 21;27:e60681. doi: 10.2196/60681.
Identifying patients with inherited colorectal cancer (CRC) syndromes offers many potential benefits. However, individuals often experience decisional conflict regarding genetic testing for CRC, and the uptake rate remains low. Given the growing popularity of genetic testing and the increasing demands on genetic service providers, strategies are needed to promote informed decision-making, increase genetic testing uptake among at-risk individuals, and ensure the rational use of genetic service resources.
This study aims to determine whether a decision aid (DA) tool could promote informed decision-making among family members regarding the genetic testing of a patient with CRC.
A single-center, parallel-group, randomized controlled trial was conducted. We randomized 82 family members of patients with CRC, who were involved in major medical decision-making for the patient, to either a DA intervention or usual care. The primary outcome was informed decision-making, assessed through measures of knowledge, decisional conflict, decision self-efficacy, and preparation for decision-making. Secondary outcomes included patients' uptake of genetic counseling and testing, participants' CRC screening behavior, healthy lifestyle scores, anxiety and depression levels, quality of life, and satisfaction with the intervention. Data were collected at baseline (T0), after the intervention (T1), and 3 months after the baseline survey (T2). The DA intervention and outcome assessments at T1 and T2 were delivered via WeChat. The effects of the intervention were analyzed using generalized estimating equation models.
Statistically significant improvements were observed in knowledge (T1: β=2.049, P<.001; T2: β=3.317, P<.001), decisional conflict (T1: β=-11.660, P<.001; T2: β=-17.587, P<.001), and decision self-efficacy (T1: β=15.353, P<.001; T2: β=22.337, P<.001) in the DA group compared with the usual care group at both T1 and T2. Additionally, the DA group showed significantly greater improvement in processed and red meat intake (β=-1.494, P<.001) at T1 and in healthy lifestyle scores (β=1.073, P=.03) at T2. No differences were found between the groups for other outcomes.
A DA tool may be a safe, effective, and resource-efficient approach to facilitate informed decision-making about genetic testing. However, the current DA tool requires optimization and further evaluation-for example, by leveraging more advanced technology than WeChat to develop a simpler and more intelligent DA system.
Chinese Clinical Trial Registry ChiCTR2100048051; https://www.chictr.org.cn/showproj.html?proj=129054.
识别患有遗传性结直肠癌（CRC）综合征的患者有诸多潜在益处。然而，个体在CRC基因检测方面常面临决策冲突，且检测接受率仍然较低。鉴于基因检测日益普及以及对基因服务提供者的需求不断增加，需要采取策略来促进明智决策，提高高危个体的基因检测接受率，并确保基因服务资源的合理利用。
本研究旨在确定决策辅助（DA）工具是否能促进CRC患者家庭成员在基因检测方面做出明智决策。
进行了一项单中心、平行组、随机对照试验。我们将82名参与患者重大医疗决策的CRC患者家庭成员随机分为DA干预组或常规护理组。主要结局是明智决策，通过知识、决策冲突、决策自我效能和决策准备等指标进行评估。次要结局包括患者接受遗传咨询和检测的情况、参与者的CRC筛查行为、健康生活方式得分、焦虑和抑郁水平、生活质量以及对干预的满意度。在基线（T0）、干预后（T1）以及基线调查后3个月（T2）收集数据。T1和T2时的DA干预及结局评估通过微信进行。使用广义估计方程模型分析干预效果。
与常规护理组相比，DA组在T1和T2时的知识（T1：β = 2.049，P <.001；T2：β = 3.317，P <.001）、决策冲突（T1：β = -11.660，P <.001；T2：β = -17.587，P <.001）和决策自我效能（T1：β = 15.353，P <.001；T2：β = 22.337，P <.001）方面有统计学意义的显著改善。此外，DA组在T1时加工肉和红肉摄入量（β = -1.494，P <.001）以及T2时健康生活方式得分（β = 1.073，P =.03）方面有显著更大的改善。两组在其他结局方面未发现差异。
DA工具可能是一种安全、有效且资源高效的方法，有助于在基因检测方面做出明智决策。然而，当前的DA工具需要优化和进一步评估，例如利用比微信更先进的技术开发更简单、更智能的DA系统。
中国临床试验注册中心ChiCTR2100048051；https://www.chictr.org.cn/showproj.html?proj=129054
