Decision Counseling and Follow-up for Shield+ Patients (DCaF)
2026年5月27日 更新者：Guardant Health, Inc.
Decision Counseling and Follow-up (DCaF) for Shield+ Patients
Prospective, observational, minimal-risk study evaluating decision-making, decisional conflict, intention to undergo complete diagnostic evaluation (CDE), and colonoscopy completion after a positive Shield TM blood-based colorectal cancer screening test result.
研究概览
详细说明
The DCaF study uses a prospective, observational design to characterize how patients make decisions following a Shield(+) screening result and to assess real-world adherence to recommended diagnostic colonoscopy.
Because the intervention of interest is the patient's naturally occurring decision-making process-not the performance of the test itself-a non-interventional design is methodologically appropriate and minimizes participant burden.
Incorporating decision counseling allows systematic evaluation of changes in preference, decisional conflict, and intention, while linkage to real-world evidence (RWE) claims data provides an efficient and objective method for determining colonoscopy completion.
This approach enables the study to identify behavioral, clinical, and system-level factors associated with follow-up adherence without altering standard clinical care.
研究类型
观察性的
注册 (估计的)
350
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：Director of Clinical Trial Operations
- 电话号码：855-698-8887
- 邮箱：dcaf@guardanthealth.com
学习地点
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19114
- Jefferson Center
-
接触：
- Principle Investigator
- 电话号码：215-503-4085
- 邮箱：ronald.myers@jefferson.edu
-
-
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
是的
取样方法
非概率样本
研究人群
Adults with a recent clinically ordered Shield™ test result who received a positive (abnormal) screening (Shield+) result.
描述
Inclusion Criteria:
- Participant is 45-75 years old at the time of ShieldTM test order.
- Participant has a valid Shield(+) test result.
- Participant is willing and able to complete the informed consent process
- Participant is able to complete the informed consent process and decision counseling session in English
Exclusion Criteria:
- Participant is already enrolled in another Guardant Health, Inc. clinical study or has received a positive MCD result for a cancer type other than CRC.
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
SHIELD Positive with Completed Colonoscopy
Patients who are intending to undergo a complete a diagnostic evaluation
|
During the decision counseling session, JH research staff will review the Complete Diagnostic Evaluation (CDE) infographic and use an online survey to guide the participant through a telephone encounter that involves the identification of patient goals that are likely to affect their decision to have CDE and not to have CDE.
|
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 |
|---|---|---|
|
CDE Decisional Conflict
大体时间：From Enrollment to the end of study at 6 months
|
Determine the level of preference for, decisional conflict related to, intention to have CDE following a Shield+ result at baseline and after decision counseling and assess change.
|
From Enrollment to the end of study at 6 months
|
|
Factors for CDE Decisional Conflict
大体时间：From Enrollment to End of Study at 6 months
|
Identify factors associated with CDE decisional conflict, intention, and preference following a positive Shield result.
|
From Enrollment to End of Study at 6 months
|
|
Factors for Changes in CDE Decisional Conflict
大体时间：From Enrollment to End of Study at 6 months
|
Identify factors associated with change in CDE preference, decisional conflict, intention, and preference.
|
From Enrollment to End of Study at 6 months
|
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。
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)
2026年6月1日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2028年6月1日
研究注册日期
首次提交
2026年5月27日
首先提交符合 QC 标准的
2026年5月27日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年6月2日
上次提交的符合 QC 标准的更新
2026年5月27日
最后验证
2026年5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.