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癌症患者用药安全与疑虑追踪的自我监测平台

2026年11月5日 更新者:University of Michigan Rogel Cancer Center

患者参与使用技术进行自我追踪用药安全事件

This clinical trial evaluates the usefulness of a self-monitoring platform for tracking medication safety events and concerns in patients with lung, colorectal, breast, and prostate cancer. Patients receiving oral anticancer agents often encounter challenges in managing complex treatment regimens, potentially life-threatening toxicities, and drug-drug and drug-food interactions at home. To achieve the goal of medication safety, they need to become "vigilant partners" in medication and toxicity self-monitoring, including timely reporting of medication events to clinicians when their care transitions back home. In this study, patients use an online self-monitoring platform to track their experiences or concerns about taking their medications, including their experiences with symptoms. This platform may be a useful way for patients to track problems they have when taking their medications at home and may help them take better care of their health.

研究概览

研究类型

介入性

注册 (估计的)

71

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

    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan Comprehensive Cancer Center

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:

  • Participants are adult patients (aged 18 years or older)
  • Diagnosed with lung, colorectal, breast, or prostate cancer
  • Are currently receiving active cancer treatments
  • Are self-managing one or more prescribed cancer medications
  • Participants must have access to technology devices (smartphone, tablet, computer) to track their experiences or concerns about medication safety events, or their family members can help them access technology devices to track the events or concerns
  • Speaks and reads English or has a support person (family member or friend) who can assist

Exclusion Criteria:

  • Can't access technology or do not use technology
  • Do not have access to the internet
  • Do not speak or read English
  • Not permitted to participate by their health care providers

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: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:Health services research (self-monitoring platform)

Patients use the self-monitoring platform to track medication-related safety events and issues at home for 6 months. Patients may receive relevant educational materials and resources via the platform or by email and/or receive follow-up contact from a nurse practitioner as needed over the 6 months. Patients are encouraged to continue using the platform for an additional 6 months after the study period, as desired.

Ancillary studies

Ancillary studies

Ancillary studies

Receive educational materials and resources

其他名称:
  • 干预教育
  • 教育干预
  • 通过教育进行干预
  • 干预,教育

Receive follow-up contact

其他名称:
  • 主动跟进
  • 临床体征随访
  • CLSFUP
  • 跟进
  • 已关注

Use self-monitoring platform

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
Self-reported system usability
大体时间:Up to 6 months

Self-reported system usability will be assessed using the 10-item System Usability Scale. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.

Up to 6 months
Perceived usefulness
大体时间:Up to 6 months

Qualitative data, including brief interview data will be analyzed and summarized through content analysis.

Up to 6 months
Ease of use
大体时间:Up to 6 months

Qualitative data, including brief interview data will be analyzed and summarized through content analysis.

Up to 6 months
Attitudes toward use
大体时间:Up to 6 months

Qualitative data, including brief interview data will be analyzed and summarized through content analysis.

Up to 6 months
Intention to use and continuous use of the system over time
大体时间:Up to 12 months

Qualitative data, including brief interview data will be analyzed and summarized through content analysis.

Up to 12 months
Self-reported patient engagement
大体时间:Up to 6 months

Self-reported patient engagement will be measured by the 9-item Twente Engagement with Ehealth Technologies Scale (TWEETS), including three dimensions, behavioral engagement, cognitive engagement, and affective engagement. Will use the overall TWEETS score to evaluate patient engagement in this study, rather than analyzing each dimension separately. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. Will use repeated measures analysis of variance to assess the changes in mean scores of patient engagement. Univariate associations between baseline personal and clinical factors and patient engagement at each time point will be assessed using correlation analyses (Pearson or Spearman), Chi-square tests, or non-parametric Mann-Whitney U tests, depending on the variable types. Multiple linear regressions will be conducted to assess associations between patient engagement and outcomes.

Up to 6 months
System usage over time
大体时间:Up to 12 months

Will be objectively recorded by the system logs and analyzed using Google Analytics (dashboard only), including parameters like the number of logins, number of tab pages clicked, number of events or concerns self-tracked, and more. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.

Up to 12 months
Patient activation levels
大体时间:Up to 6 months

Patient activation levels will be measured by the Short Form of Patient Activation Measure. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.

Up to 6 months
Medication self-management ability
大体时间:Up to 6 months

Medication self-management ability will be measured by the Measure of Medication Self-Management. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.

Up to 6 months
Symptom distress
大体时间:Up to 6 months

Symptom distress will be measured by the 19-item MD Anderson Symptom Inventory. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.

Up to 6 months
Health related quality of life
大体时间:Up to 6 months

Health-related quality of life will be measured by the 27-item Functional Assessment of Cancer Therapy - General. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.

Up to 6 months
Number of emergency room visits
大体时间:Up to 12 months

Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.

Up to 12 months
Number of hospitalizations
大体时间:Up to 12 months

Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.

Up to 12 months
User experiences with the system
大体时间:Up to 6 months

Participants' user experiences with the system, such as perceived facilitators or barrios to system use, along with their suggestions for system improvement, will be collected through a brief individual interview. Qualitative data, including brief interview data will be analyzed and summarized through content analysis.

Up to 6 months

次要结果测量

结果测量
措施说明
大体时间
Self-tracked, structured medication safety events or concerns
大体时间:Up to 12 months

To understand the nature and causes of events and concerns, self-tracked, structured medication safety events or concerns tracking data from the system, such as the number and types of events or concerns self-tracked, will be summarized using descriptive statistics. The free-text tracking data from the system will be analyzed and summarized through content analysis or natural language processing techniques, depending on data volume.

Up to 12 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。

调查人员

  • 首席研究员:Yun Jiang、University of Michigan Rogel Cancer Center
  • 首席研究员:Yang Gong、UTHealth Houston McWilliam School of Biomedical Informatics

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)

2026年1月9日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2027年3月1日

研究注册日期

首次提交

2025年12月4日

首先提交符合 QC 标准的

2025年12月4日

首次发布 (实际的)

2025年12月18日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11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)?

不

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

在美国制造并从美国出口的产品

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.

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