Pre-Clinic Visit Online Education for Thyroid Cancer
2026年8月29日 更新者：Allen Ho、Cedars-Sinai Medical Center
A Randomized Controlled Trial Evaluating Educational Resources for Patients With Thyroid Cancer
Through a pilot randomized controlled trial (RCT), we aim to test the feasibility and preliminary impact of two online educational resources among adult patients with thyroid cancer.
Each online program can be accessed on the patient's personal device, and will be provided to the patient following a diagnosis of thyroid cancer but before meeting with their surgeon to discuss treatment options.
The goal of the resource is to educate patients on the various treatment options for thyroid cancer prior to surgical consultation, so that clinic visit time can be better utilized to discuss patient questions and priorities, and support shared decision making.
Clinical (TC-MAX; thyroid cancer related anxiety) and behavioral outcomes (decisional conflict, shared-decision making, treatment decision) will be assessed via online surveys 1-day and 14-days post-visit.
研究概览
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zoe Krut, MSHS
- 电话号码：310-423-0699
- 邮箱：Zoe.Krut@cshs.org
研究联系人备份
- 姓名：Michael Fine, MSHS
- 邮箱：michael.fine@cshs.org
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
Newly diagnosed with either:
- ≤2cm Bethesda 6 thyroid nodule (papillary thyroid carcinoma) (T1N0)
- ≤2cm Bethesda 5 thyroid nodule
- ≤2cm Bethesda 3-4 thyroid nodule with molecular testing that confers >75% risk of malignancy
- Able to understand and complete questionnaires independently in English
- Access to an internet-enabled device for online surveys and intervention access
Exclusion Criteria:
- Cognitive impairment or other condition that, in the opinion of the investigators, would interfere with protocol participation
- Has nodule >2cm in size, or with non-papillary thyroid carcinoma histology
- High-grade or poorly differentiated papillary thyroid carcinoma (PTC) variants
- Central or lateral neck lymphadenopathy suspicious for PTC
- Unfavorable nodule location, to be determined by the surgeon (e.g. Near dorsal surface (by recurrent laryngeal nerve); adjacent to trachea (risk of cartilage invasion)
- Recurrent thyroid cancer case
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：THRIVE
Participants randomized to the THRIVE arm will be sent a link to access the THRIVE portal up to 3 weeks prior to their clinic visit.
The THRIVE modules can take between 20-35 minutes to complete.
Completion of the THRIVE modules prior to the clinic visit will be monitored and confirmed by study staff.
Upon completing the program, a report summarizing the conversation and questions/comments brought up by the patient will be shared with their physician prior to the clinic visit.
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THRIVE is a tailored AI agent that provides patient education and assists in decision-making specifically for thyroid cancer patients.
Using HIPAA-compliant protocols and an empathic approach, THRIVE can (1) establish patient priorities, (2) guide patients through decision tools, and (3) integrate detailed notes into the electronic health record (EHR).
Such computer-generated notes have been found to be higher quality, more comprehensive, better organized, and with greater relevance compared with physician-documented notes.
Altogether, this solution tackles a time-intensive and laborious task, expanding time and bandwidth for decision-making.
Moreover, integration with existing infrastructure like the EHR can help promote clinical adoption.
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假比较器：Education Control
Participants randomized to the education control arm will be sent a link to access the 2-page American Cancer Society (ACS) handout: "After a Thyroid Cancer Diagnosis."
The handout can take between 5-15 minutes to read through.
Completion of the ACS handout prior to the clinic visit will be monitored and confirmed by study staff.
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The 2-page American Cancer Society (ACS) flyer (No. 0827.60 Rev. 3/25) is titled "After a Thyroid Cancer Diagnosis" and provides brief information about "Treatment for thyroid cancer", "What to expect before and during treatment", "What to expect after treatment", "Staying healthy", and "Dealing with your feelings", as well as recommendations on questions to ask a physician for each of the above topics.
The flyer also provides the patient with a link to the ACS website and a direct phone number.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
TC-MAX
大体时间：Baseline, 1-day post clinic visit, 14-days post clinic visit
|
Thyroid cancer-related anxiety as measured by the 18-item TC-MAX questionnaire created by Dr. Allen Ho at Cedars-Sinai.
It is a psychometric scale assessing thyroid cancer-related anxiety across three different subscales (Collective Anxiety, Ultrasound Anxiety, and Fear of Recurrence/Progression). Scale range is between 0-100, with higher scores indicating greater anxiety.
Means and standard deviations will be used to describe the scores.
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Baseline, 1-day post clinic visit, 14-days post clinic visit
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Decisional Conflict Scale
大体时间：1-day post clinic visit
|
Decisional conflict as measured by the 16-item Traditional Decisional Conflict Scale (DCS) - Statement Format.
This scale assesses personal perceptions of uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.
This questionnaire uses a 5-point Likert scale, from strongly agree to strongly disagree.
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1-day post clinic visit
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Shared Decision Making
大体时间：1-day post clinic visit
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Patient perception of shared decision making as measured by the 9-item Shared Decision Making Questionnaire (SDM-Q-9).
This questionnaire measures the extent to which patients are involved in the process of decision-making from the perspective of the patient.
This questionnaire uses a 6-point Likert scale, from completely agree to completely disagree.
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1-day post clinic visit
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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System Usability Scale
大体时间：1-day post clinic visit
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System usability as measured by the validated, 10-item System Usability Scale (SUS).
This attitude Likert scale gives a global assessment of usability.
Each item is rated on a scale of 0 to 5, with higher scores indicating greater usability.
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1-day post clinic visit
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Allen Ho, MD、Cedars-Sinai Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2027年8月1日
初级完成 (估计的)
2028年7月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年7月2日
首先提交符合 QC 标准的
2026年7月2日
首次发布 (实际的)
2026年7月8日
研究记录更新
最后更新发布 (实际的)
2026年9月1日
上次提交的符合 QC 标准的更新
2026年8月29日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.