National Comprehensive Cancer Network (NCCN) Decision Support Tool for Patients With NSCLC
2022年3月7日 更新者：University of California, San Francisco
Acceptability and Effectiveness of a Novel Internet -Based Decision-Support Aid Based on the NCCN Non-Small Cell Lung Cancer Patient Guidelines
This study involves the evaluation of a decision support tool, based on the patient version of the NCCN guidelines, for the non-small cell lung cancer patient population.
研究概览
详细说明
This study involves the evaluation of a decision support tool, based on the patient version of the NCCN guidelines, for the non-small cell lung cancer patient population.
The decision support tool is offered by a trained coordinator to the patient and then utilized during an initial consultation.
Patients complete forms before and after the visit indicating their level of decisional conflict, satisfaction, and satisfaction with decision.
Pre-determined indices of quality of care were also collected by the study team.
研究类型
介入性
注册 (实际的)
76
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。
学习地点
-
-
California
-
San Francisco、California、美国、94143
- University of California, San Francisco
-
-
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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Over age of 18
- Able to provide informed consent
- Able to use a web-based interface
- Histologically proven or clinically apparent diagnosis of non-small cell lung cancer
- Newly diagnosed, with new primary occurrence of NSCLC, or diagnosed with a new recurrence or new progression of existing disease, and not yet treated for the new problem
- Being seen in consultation at thoracic oncology clinics
Exclusion Criteria:
- Unable to fill out questionnaires
- Already treated for the current diagnosis of a new primary occurrence of NSCLC, or already treated for the new recurrence or new progression of existing disease
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：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Decision support tool
Patients in this single-arm study all receive training in use of a decision support tool by a trained coordinator.
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computerized online decision support tool
|
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 |
|---|---|---|
|
Quality of Care
大体时间：1 Day
|
Change in percentage of patients receiving care according to 6 selected NCCN recommendations
|
1 Day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Decisional Conflict
大体时间：1 Day
|
Change in level of decisional conflict will be assessed by the Decisional Conflict Scale (DCS).
Assessment will be completed before and after consultation.
The DCS is a scale designed to measure patients' uncertainty in making health-related decisions, factors contributing to uncertainty, and patients' perceived effective decision-support.
The DCS has 16 items and uses a five-point Likert scale for each item.
The total score ranging from 0-64 is divided by 16 and then multiplied by 25 to calculate a final total score with 0 indicating low conflict and 100 indicating high conflict.
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1 Day
|
|
Satisfaction with Health Care Decision
大体时间：1 Day
|
Satisfaction will be assessed using the Patient Satisfaction with Health Care Decision (SWD) six-item scale.
The SWD will be completed once after the consultation.
The range of scoring on this instrument is 0-30, with 30 indicating the highest satisfaction with decision.
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1 Day
|
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Characterize Decisional Support Preference
大体时间：1 Day
|
Patients' preferred style of decision making with their physician will be assessed using the Decision Making Preference Questionnaire (DMPQ).
The DMPQ will be completed once before the consultation.
The DMPQ consists of a single question with five choices, ranging from a preference to have the doctor make all of the decisions (passive) to the patient making all of the decisions themselves about their treatment (active) or the intermediate state of shared decision making.
There are choices from 1-5 with 5 indicating the most active decision making preference.
|
1 Day
|
|
Quality of Life by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire
大体时间：1 Day
|
Quality of life will be assessed using the FACT-L quality of life instrument, a 44-item self-report questionnaire that uses a five-point Likert scale.
The FACT-L will be completed once before the consultation.
The FACT-L is graded on a scale from 0-84 with a lung cancer subscale that ranges from 0-24 with the higher scores indicating better quality of life.
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1 Day
|
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Lung Cancer Symptom Evaluation Score by the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17)
大体时间：1 Day
|
Patients' symptoms will be evaluated using the National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17), a 17-item patient-reported questionnaire that uses a five-point Likert scale and is scored from 0-68.
It includes three subscales: Disease-Related Subscale, Treatment Side Effects, and Functional Well-Being.
The NFLSI-17 will be completed once before the consultation.
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1 Day
|
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Post Consultation Agreement Between Patient and Physician
大体时间：1 Day
|
By using a post-consultation questionnaire, we will determine the level of agreement between patient and physician with respect to treatments discussed and recommended, prognosis, and expected tolerance.
|
1 Day
|
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：Sue Yom, MD, PhD、University of California, San Francisco
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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 (实际的)
2015年2月1日
初级完成 (实际的)
2017年9月1日
研究完成 (实际的)
2018年9月1日
研究注册日期
首次提交
2019年5月27日
首先提交符合 QC 标准的
2019年6月9日
首次发布 (实际的)
2019年6月11日
研究记录更新
最后更新发布 (实际的)
2022年3月22日
上次提交的符合 QC 标准的更新
2022年3月7日
最后验证
2022年3月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Data will be shared on request.
IPD 共享时间框架
available now
IPD 共享访问标准
request to Principal Investigator
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
decision support tool的临床试验
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Medical University of South CarolinaNational Center for Advancing Translational Sciences (NCATS)完全的
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UConn HealthUniversity of Texas at Austin; Oregon Social Learning Center邀请报名
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University of Alabama at BirminghamNational Cancer Institute (NCI)招聘中
-
Women's College HospitalRyerson University撤销
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Potomac Health FoundationsNational Institutes of Health (NIH); National Institute of Drug Abuse招聘中