A Pilot Feasibility Study of an Intervention to Decrease Overtreatment of Low-risk Thyroid Cancer

项目摘要 近90%的低风险甲状腺乳头状癌患者接受甲状腺全切除术， 尽管微创治疗可以提供相同的复发率和生存率，但其发病率最高。 对这些患者的过度治疗导致严重的患者伤害和大量的成本。目前，患者 未满足的信息需求有助于接受甲状腺全切除术。低风险患者 乳头状甲状腺癌将受益于满足其信息需求并增加的干预措施 参与决策过程的能力。这一建议是支持我们长期发展的关键一步。 通过干预手术决策减少低风险甲状腺癌过度治疗的目标。 我们的研究团队开发了一种名为CQUPLE的新型干预措施，其中包括（1）并排图表， 比较低风险甲状腺癌的所有三种管理方案的循证信息，包括 预期结果和（2）一个问题提示列表，其中包含考虑询问的关键问题， 外科医生该干预措施以社会认知理论为基础，旨在提高患者对 治疗选择及其结果、患者激活和决策的自我效能。这项建议 将在一个卫生系统的三个诊所试点CQUPLE。我们提出了一个试点的可行性随机 在50例低危甲状腺乳头状癌患者中进行对照试验，以评估 CQUPLE（目标1）和描述结局分布（目标2）。 拟议研究的结果将提供必要的初步数据，为未来的大规模 规模实用有效性试验，以测试CQUPLE对患者选择甲状腺全切除术的影响。CQUPLE 是一种低成本，可扩展，以患者为导向的干预措施，具有创新性，因为它结合了两个互补的 这些组件通过不同的机制来满足患者的信息和决策需求。的 研究意义重大，因为降低低风险甲状腺癌患者的甲状腺全切除率 有可能减少患者伤害并改善长期结局。我们的多学科团队 在行为干预设计和测试方面的成功合作历史和经验， 随机对照试验使我们能够很好地实现这个奖项的目标。

PROJECT SUMMARY Nearly 90% of patients with low-risk papillary thyroid cancer undergo total thyroidectomy, the treatment option with the greatest morbidity, even though less invasive options offer equivalent recurrence and survival. Overtreatment of these patients results in significant patient harm and substantial costs. Currently, patients have unmet informational needs that contribute to the uptake of total thyroidectomy. Patients with low-risk papillary thyroid cancer would benefit from an intervention that meets their informational needs and increases their ability to participate in the decision-making process. This proposal is a key step to support our longer-term goal of reducing overtreatment of low-risk thyroid cancer by intervening on surgical decision making. Our research team developed a novel intervention called CQUPLE, which includes (1) a Chart of side-by-side, evidence-based information comparing all three management options for low-risk thyroid cancer, including expected outcomes and (2) a Question Prompt List that contains key questions to consider asking the surgeon. The intervention is grounded in social cognitive theory and aims to increase patient awareness of treatment options and their outcomes, patient activation, and self-efficacy for decision making. This proposal will pilot CQUPLE at three clinic sites in a single health system. We propose a pilot feasibility randomized controlled trial in 50 patients with low-risk papillary thyroid cancer to evaluate the feasibility and acceptability of CQUPLE (Aim 1) and characterize the distribution of outcomes (Aim 2). The results of the proposed research will provide the preliminary data necessary to prepare for a future, large- scale pragmatic efficacy trial to test the effect of CQUPLE on patients’ choice for total thyroidectomy. CQUPLE is a low-cost, scalable, patient-directed intervention that is innovative because it combines two complimentary components that work to meet patients’ informational and decisional needs through different mechanisms. The research is significant because reducing rates of total thyroidectomy for patients with low-risk thyroid cancer has the potential to decrease patient harm and improve long-term outcomes. Our multidisciplinary team’s history of successful collaboration and experience in behavioral intervention design and testing with randomizes controlled trials make us well positioned to achieve the aims of this award.