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: 10697332
• 负责人: KRISTI D. GRAVES
• 金额: $ 31.22万
• 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/10697332
• 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; Dimensions; District of Columbia; Dose; Education; Enrollment; Equilibrium; Evaluation; Face; Fatigue; Feedback; Frequencies; Frustration; Guidelines; Hospitals; Individual; Intervention Trial; Knowledge; Malignant neoplasm of thyroid; Measures; Mediating; Mediator; 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; Recommendation; Recurrence; Recurrent Malignant Neoplasm; Regrets; Reporting; Risk; Salivary; Salivary Glands; Second Primary Cancers; Self Efficacy; Site; Survival Rate; Symptoms; Testing; Uncertainty; United States; Xerostomia; arm; cancer biomarkers; cancer recurrence; child bearing; 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 based decision aid; 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).

摘要。诊断为中等风险分化型甲状腺癌（DTC）的个体 关于放射性碘（RAI）的风险和益处的重大不确定性。RAI是常规治疗， 根据记录的生存率增加，高风险DTC患者。相比之下，RAI通常 不用于低风险DTC患者，因为它不会降低复发率，也不会增加生存率。由于 由于缺乏随机对照试验的数据，关于获益和 中等风险DTC患者的RAI治疗风险。临床实践指南现在建议 考虑中等风险疾病患者的RAI。因此，大多数中等风险DTC患者 选择单独手术还是手术加RAI。来自我们团队和其他人的数据表明， 缺乏关于RAI潜在副作用的信息，包括唾液腺损伤、鼻和泪腺损伤 症状、生殖影响、继发性恶性肿瘤和对生活质量的影响。唾液腺损伤 在RAI后21-77%的患者中以剂量依赖性方式发生。其他RAI剂量依赖性效应 包括泪和鼻症状。患者还报告疲劳增加和生活质量下降， 尤其是RAI的并发症中等风险DTC患者需要平衡 了解RAI的风险和益处。使用有关RAI效益的既定数据， 关于RAI副作用频率的新数据，我们寻求开发和评估决策辅助（DA） 促进这些患者对RAI治疗做出明智的决定。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（UG 3目标1）。我们将使用初步数据， 输入和发布的指导方针，以创建DA的大纲。我们将开发一个基于Web的原型， 对16例患者（8例有RAI，8例无RAI）进行可用性测试。我们将修改DA并招募30名患者 与新诊断的中等风险DTC的试点随机对照试验的DA，以检查 DA的可行性、可用性和满意度。我们将DA（n=20）与常规护理（UC）进行比较 教育控制网站（n=10），以探讨DA对RAI，知识， 随机分组后4周，自我效能、决策冲突和后悔。我们将使迭代 在UH 3阶段（3-7年; UH 3目标2，3），我们将进行多中心随机 在三个临床试验点对最终DA进行对照试验。我们将筛查800名新诊断的 中等风险DTC并招募和随机化400名患者（n=200 DA组; n=200 UC组）。我们会进行 在基线和随机化后1周、4周和6个月进行评估。我们的主要成果是 4周时的知情选择（目标2）。次要结果包括知识，决策冲突和遗憾， 治疗满意度。我们将在6个月时探索所有患者的QOL。我们将研究是否自我- 患者-医生沟通的有效性和满意度介导了DA的效果（目的3）。