癌症患者用药安全与疑虑追踪的自我监测平台
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
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109
- University of Michigan Comprehensive Cancer Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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:
Receive follow-up contact
其他名称:
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
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
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
- 泌尿生殖系统疾病
- 生殖器疾病
- 生殖器肿瘤,男性
- 泌尿生殖系统肿瘤
- 按部位分类的肿瘤
- 肿瘤
- 生殖器疾病,男性
- 前列腺疾病
- 男性泌尿生殖系统疾病
- 肠道疾病
- 呼吸道疾病
- 消化道肿瘤
- 消化系统肿瘤
- 消化系统疾病
- 肠胃疾病
- 肠道肿瘤
- 直肠疾病
- 肺部疾病
- 呼吸道肿瘤
- 胸部肿瘤
- 结肠疾病
- 皮肤病
- 乳腺疾病
- 皮肤和结缔组织疾病
- 前列腺肿瘤
- 肺肿瘤
- 结直肠肿瘤
- 乳腺肿瘤
- 医疗保健质量,访问和评估
- 调查技术
- 流行病学方法
- 数据收集
- 医疗保健评估机制
- 医疗保健质量
- 公共卫生
- 环境与公共卫生
- 卫生服务
- 医疗机构的劳动力和服务
- 儿童健康服务
- 社区卫生服务
- 预防保健服务
- 社会经济因素
- 人口特征
- 免疫学技术
- 遗传技术
- 流行病学研究
- 流行病学研究特征
- 染色质免疫沉淀
- 高通量核苷酸测序
- 序列分析
- 序列分析,DNA
- 免疫沉淀
- 队列研究
- 方法
- 采访作为主题
- 早期干预,教育
- 教育地位
- 染色质免疫沉淀测序
- 后续研究
其他研究编号
- UMCC 2025.050
- NCI-2025-08754 (注册表标识符:CTRP (Clinical Trial Reporting Program))
- HUM00272763 (其他标识符:University of Michigan)
- R01HS027846 (美国 AHRQ 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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