Use of a decision aid to resolve uncertainty about radioactive iodine treatment in patients with intermediate-risk thyroid cancer: the Radiance trial

使用决策辅助解决中危甲状腺癌患者放射性碘治疗的不确定性：Radiance 试验

• 批准号: 10523258
• 负责人: KRISTI D. GRAVES
• 金额: $ 34.09万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-05 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10523258
• 关键词: American Cancer Society; Area; Benefits and Risks; Biological Markers; Cancer Patient; Cancer Survivor; Client satisfaction; Clinical Practice Guideline; Communication; Conflict (Psychology); Data; Decision Aid; Decision Making; Dental caries; Development; Diagnosis; District of Columbia; Dose; Enrollment; Equilibrium; Face; Fatigue; Feedback; Frequencies; Frustration; Guidelines; Hospitals; Individual; Intervention Trial; Knowledge; Malignant neoplasm of thyroid; Measures; Mediating; Mediator of activation protein; Medical; Modeling; Newly Diagnosed; Nose; Online Systems; Operative Surgical Procedures; Oral cavity; Outcome; Participant; Pathway interactions; Patients; Persons; Phase; Physicians; Prospective Studies; Protocols documentation; Publishing; Quality of life; Radioactive Iodine; Randomized; Randomized Controlled Trials; Recurrence; Regrets; Reporting; Risk; Salivary; Salivary Glands; Second Primary Cancers; Self Efficacy; Site; Survival Rate; Symptoms; Testing; Uncertainty; United States; Xerostomia; arm; base; cancer biomarkers; cancer recurrence; clinical research site; disorder risk; experience; high risk; lacrimal; pilot test; primary outcome; prototype; radioiodine therapy; recruit; reproductive; satisfaction; secondary outcome; side effect; treatment as usual; usability; usual care arm; web site

ABSTRACT. Individuals diagnosed with intermediate risk differentiated thyroid cancer (DTC) encounter significant uncertainty regarding the risks and benefits of radioactive iodine (RAI). RAI is routine treatment for patients with high risk DTC based on the documented increased rate of survival. In contrast, RAI is generally not used for patients with low risk DTC, as it does not decrease recurrence nor increase survival. Due to absence of data from randomized controlled trials, controversy remains regarding the balance of benefits and risks for RAI treatment for patients with intermediate risk DTC. Clinical practice guidelines now suggest consideration of RAI in patients with intermediate risk disease. Thus, most patients with intermediate risk DTC choose between surgery alone vs surgery plus RAI. Data from our team and others indicate patients report a lack of information about the potential side effects of RAI including salivary gland damage, nasal and lacrimal symptoms, reproductive impact, secondary malignancies, and effects on quality of life. Salivary gland damage occurs among 21-77% of patients after RAI in a dose-dependent manner. Other RAI-dose dependent effects include lacrimal and nasal symptoms. Patients also report increased fatigue and decreased quality of life, particularly with complications from RAI. Patients with intermediate risk DTC have a need to balance what is known about the risks and benefits of RAI. Using established data concerning RAI benefits and compelling new data about the frequency of side effects due to RAI, we seek to develop and evaluate a decision aid (DA) to promote informed decisions about RAI treatment among these patients. Guided by the Ottawa Decision Support Framework, we will first develop and pilot test the DA (UG3 Aim 1). We will use preliminary data, team input and published guidelines to create an outline of the DA. We will develop a web-based prototype and conduct usability testing with 16 patients (8 with, 8 without RAI). We will revise the DA and recruit 30 patients with newly diagnosed intermediate risk DTC for a pilot randomized controlled trial of the DA to examine the feasibility, usability and satisfaction with the DA. We will compare the DA (n=20) to a usual care (UC) educational control website (n=10) to explore the effect of the DA on informed choice about RAI, knowledge, self-efficacy, and decisional conflict and regret at 4 weeks post-randomization. We will make iterative refinements to the DA. In the UH3 phase (years 3-7; UH3 Aims 2, 3), we will conduct a multi-site randomized controlled trial of the finalized DA at three clinical sites. We will screen 800 patients with newly diagnosed intermediate risk DTC and enroll and randomize 400 patients (n=200 DA arm; n=200 UC arm). We will conduct assessments at baseline and 1 week, 4 weeks and 6 months post-randomization. Our primary outcome is informed choice at 4 weeks (Aim 2). Secondary outcomes include knowledge, decisional conflict and regret, and treatment satisfaction. We will explore QOL among all patients at 6 months. We will examine whether self- efficacy and satisfaction with patient-physician communication mediate the effect of the DA (Aim 3).

抽象的。被诊断为中等风险分化的甲状腺癌（DTC）遇到的人 放射性碘（RAI）的风险和益处的重大不确定性。 RAI是常规治疗 高风险DTC的患者基于记录的生存率提高。相反，Rai通常是 不适用于低风险DTC的患者，因为它不会降低复发或增加生存率。由于 没有随机对照试验中的数据，关于利益的平衡和 中间风险DTC患者的RAI治疗风险。现在建议的临床实践指南 考虑中等风险疾病患者的RAI。因此，大多数患有中级风险DTC的患者 仅在手术与手术和RAI之间进行选择。我们团队和其他人的数据表明患者报告了 缺乏有关RAI潜在副作用的信息，包括唾液腺损伤，鼻和泪 症状，生殖影响，继发性恶性肿瘤以及对生活质量的影响。唾液腺损伤 RAI在RAI后以剂量依赖性方式发生在21-77％的患者中。其他RAI剂量依赖性效果 包括泪和鼻症状。患者还报告疲劳和生活质量降低， 特别是RAI的并发症。患有中级风险DTC的患者需要平衡什么 知道RAI的风险和好处。使用有关RAI福利和引人注目的既定数据 有关RAI引起的副作用频率的新数据，我们寻求制定和评估决策援助（DA） 促进这些患者中关于RAI治疗的知情决定。在渥太华决定的指导下 支持框架，我们将首先开发和试点测试DA（UG3 AIM 1）。我们将使用初步数据，团队 输入和已发布的指南，以创建DA的概述。我们将开发一个基于Web的原型， 对16名患者进行可用性测试（8例，8例无RAI）。我们将修改DA并招募30名患者 新诊断为中间风险DTC用于DA的试验随机对照试验，以检查 DA的可行性，可用性和满意度。我们将将DA（n = 20）与通常的护理（UC）进行比较 教育控制网站（n = 10）探讨DA对RAI，知识，知识选择的影响 随机化4周的自我效能感以及决策冲突和遗憾。我们会迭代 DA的改进。在UH3阶段（3-7年； UH3目标2，3），我们将进行多站点随机分组 最终DA在三个临床部位的对照试验。我们将筛选800名新诊断的患者 中级风险DTC并招募和随机分组400名患者（n = 200 da ARM； n = 200 UC ARM）。我们将进行 随机化后的基线和1周，4周和6个月的评估。我们的主要结果是 4周的知情选择（AIM 2）。次要结果包括知识，决策冲突和遗憾， 和治疗满意度。我们将在6个月的所有患者中探索QOL。我们将检查自我是否 患者 - 医学沟通的功效和满意度介导了DA的效果（AIM 3）。