Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer: The Radiance Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 408
- 试验地点
- 3
- 主要终点
- Informed choice about RAI treatment
研究概览
简要总结
The goal of this study is to learn if a decision aid (DA) website helps people with thyroid cancer make informed decisions about radioactive iodine (RAI) treatment. The main questions it aims to answer are: - Does the decision aid help participants understand the risks and benefits of RAI treatment? - Does it help participants make choices that reflect what matters most to them? - How does the decision aid compare to usual care in supporting patients through this decision? Participants who have been recently diagnosed with intermediate-risk differentiated thyroid cancer (DTC) will be randomly assigned to one of two groups. One group will receive a special decision aid website. This site includes detailed information about RAI, short videos, drop-down menus with extra details, exercises to help clarify values, and tools to help patients prepare questions for their doctor. The other group will receive the American Cancer Society (ACS) website. This site gives basic information about RAI but does not include interactive tools and is not specific to intermediate-risk thyroid cancer. Follow up surveys will be sent to the participants periodically, first at the start of the study, and again at 1 week, 4 weeks, and 6 months later.
Researchers will compare how the two groups differ in making informed decisions. The decision aid is meant to support, not replace, a conversation with the medical team. Doctor recommendations remain an important part of treatment decisions.
详细描述
Background Information Differentiated thyroid cancer (DTC) presents with a spectrum of disease severity, which is associated with varying recurrence rates. Radioactive iodine (RAI) treatment is often considered for moderate to high recurrence risk cases. Patients with low-risk DTC typically have very low recurrence rates, and RAI is generally not used. In contrast, patients with high-risk DTC commonly receive RAI due to a substantial risk of recurrence. The intermediate-risk group experiences uncertainty regarding the potential benefit of RAI in reducing recurrence risk. This study is designed to evaluate the effect of a decision aid (DA) on the decision-making process among patients with intermediate-risk DTC.
Rationale In 2020, an estimated 860,000 individuals in the United States were living as thyroid cancer survivors, with approximately 55% classified as having low-risk disease. Use of RAI in patients with high-risk DTC has been associated with extended survival and reduced recurrence. Among patients with intermediate-risk DTC, 15-year survival rates remain high at 85% to 93%. However, the benefits of RAI in this population may apply only to certain subgroups, such as older individuals or those with larger tumors.
The study intervention consists of a web-based decision aid called RAI Decisions. Eligible patients are randomized to either the DA arm or a usual care (UC) arm. The UC arm receives standard educational material from the American Cancer Society (ACS) website.
Decisions regarding RAI in intermediate-risk DTC are more complex due to several factors: variability in disease severity, limited data on risk and benefit, and differences among physicians and institutions in treatment recommendations and communication practices. Additional factors influencing decision-making may include age, comorbidities, and fertility considerations. Current clinical practice guidelines recommend consideration of RAI in this group, rendering the decision one of personal preference. These guidelines have contributed to a shift away from over treatment of DTC.
RAI usage within the intermediate-risk category is often influenced by disease severity markers (e.g., number of lymph nodes involved, thyroglobulin levels), physician specialty and perceptions, geographic proximity to care, and institutional practices such as multidisciplinary tumor board discussions. Standard of care currently ranges from minimal patient engagement to robust shared decision-making. The decision aid used in this study does not intend to direct or alter clinical decisions regarding RAI use. Instead, it is designed to support informed, value-based decisions through balanced educational content. The decision aid clearly states that it does not provide medical advice and that treatment decisions should be made in consultation with the patient's clinical team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 and older
- •Patients diagnosed with intermediate risk DTC < 6 months ago and who are making a decision about RAI treatment
- •Ability to understand the information conveyed in the informed consent form, pose questions and process answers (e.g., no cognitive impairment per direct consultation with the patient's physician), and, finally, provided informed consent to participate.
- •Participants willingness to be contacted and remain available to complete study activities throughout the duration of the study.
排除标准
- •Diagnosis of low risk or high risk DTC
- •Prior history of RAI
- •Clinical contraindications that prevent consideration of RAI (e.g., pregnancy, lactation, neutropenia if considering high dose of RAI)
研究组 & 干预措施
Usual Care Condition
Patients randomized in the Usual Care Condition arm will receive a link for the American Cancer Society website on Radioactive Iodine (Radioiodine) Therapy for Thyroid Cancer as our comparison.
干预措施: Usual Care (Behavioral)
Decision Aid
Patients randomized in the RAI Decision website arm will receive information about intermediate risk DTC; treatment options for intermediate risk DTC following thyroidectomy; clarification of the decision to be made (to have RAI therapy or not); risks and benefits of each treatment option, including potential side effects related to salivary gland damage, lacrimal and nasal symptoms, delay in childbearing; clarification of values and preferences around treatment options; structured guidance around communication with the healthcare team and information to support decision-making about RAI.
干预措施: Decision Aid (Behavioral)
结局指标
主要结局
Informed choice about RAI treatment
时间窗: 4 weeks
The primary outcome is informed choice measured with the Multi-Dimensional Measure of Informed Choice (MMIC). The scores for informed choice include two components: knowledge categorized as high/low based on the mid-point in the range of scores on the knowledge measure (minimum score of 0 and maximum score of 10; higher scores indicate greater knowledge) and values (attitudes) that are categorized as positive or negative based on the mid-point on the attitude items (minimum score of 4; maximum score of 28; higher scores more greater alignment of the RAI treatment decision with personal values. Informed choice is characterized as informed or uninformed. An informed choice means a decision based on high knowledge and values (attitudes) that align with the patient's preferences and final treatment decision. An uninformed choice occurs when a patient has low knowledge or makes a decision that doesn't match their personal values and attitudes.
次要结局
- Knowledge about RAI(Baseline)
- Knowledge about RAI(1 week)
- Knowledge about RAI(4 weeks)
- Decisional Conflict(Baseline)
- Decisional Conflict(1 week)
- Decisional Conflict(4 weeks)
- Decisional Regret(4 weeks)
- Knowledge about RAI(6 months)
- Decisional Conflict(6 months)
- Decisional Regret(6 months)
- Satisfaction with Decision(6 months)
- Informed choice about RAI treatment(6 months)