An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy
2022年2月16日 更新者：Peking Union Medical College Hospital
An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy: a Randomized Controlled Trial
The aim of this study is to evaluate benefits of the app in breast cancer patients receiving the docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy.
The investigators hypothesized that the addition of the app to conventional adverse event management would increase quality of life (QoL) scores and reduce adverse events.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (预期的)
108
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：Yan Li, Doctor
- 电话号码：+86 17600352101
- 邮箱：liyan0551@163.com
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
女性
描述
Inclusion Criteria:
- pathological diagnosis of invasive breast cancer
- breast surgery within the past 2-8 weeks
- adult female
- must be able to use mobile phones
- speak and write Chinese fluently to sign the informed consent
Exclusion Criteria:
- severe comorbidity that interferes with outcome evaluation
- insufficient Chinese language skills
- inability to use mobile phones
- cognitive disability to give informed consent
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：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：The intervention group
The intervention group will receive conventional adverse event management and have access to the smartphone app during chemotherapy.
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At their enrollment, patients will receive detailed introduction and adequate assistance on the use of the smartphone app.
The smartphone app will offer proper advice for adverse event management based on calculated results by artificial intelligence on the innovative app, which was developed by YL et al.
It was specifically intended for risk prediction, early prevention, as well as management of symptoms and concerns during adjuvant chemotherapy in the treatment of breast cancer.
The app consisted of 4 modules: (1) Module 1: clinical data collection.
(2) Module 2: risk evaluation for 12 common adverse events during breast cancer chemotherapy.
(3) Module 3: personalized prophylaxis based on predicted risks of adverse events.
(4) Module 4: Q&A platform.
Chemotherapy-related adverse events in the control group will be managed with symptomatic treatment, dietary and lifestyle prescription according to the doctors' clinical experience.
For example, colony-stimulating factors and antibiotics may be used for febrile neutropenia, loperamide (or diphenoxylate plus atropine) as prophylaxis for diarrhea, together with eating low-lactose and low-fat frequent small meals.
5-hydroxytryptamine 3 receptor antagonist, neurokinin 1 receptor antagonist, and/or dexamethasone would be prescribed for patients at high risks of vomiting.
|
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有源比较器：The control group
The control group will receive conventional adverse event management during chemotherapy.
Chemotherapy-related adverse events in the control group will be managed with symptomatic treatment, dietary and lifestyle prescription according to the doctors' clinical experience.
|
Chemotherapy-related adverse events in the control group will be managed with symptomatic treatment, dietary and lifestyle prescription according to the doctors' clinical experience.
For example, colony-stimulating factors and antibiotics may be used for febrile neutropenia, loperamide (or diphenoxylate plus atropine) as prophylaxis for diarrhea, together with eating low-lactose and low-fat frequent small meals.
5-hydroxytryptamine 3 receptor antagonist, neurokinin 1 receptor antagonist, and/or dexamethasone would be prescribed for patients at high risks of vomiting.
|
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 |
|---|---|---|
|
Change from baseline quality of life scores at 4 months
大体时间：1 day before the first cycle, and 4 months after the first cycle (each cycle is 21 days)
|
Quality of life scores will be assessed using the simplified Chinese version of the Organization for Research and Treatment of Cancer (EORTC QLQ-C30, version 3).
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1 day before the first cycle, and 4 months after the first cycle (each cycle is 21 days)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence and severity of 12 common adverse events
大体时间：4 months after the first cycle (each cycle is 21 days)
|
The incidence and severity of 12 common adverse events will be measured with the WHO-toxicity scale.
|
4 months after the first cycle (each cycle is 21 days)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Login times
大体时间：Documented automatically by the application every two weeks
|
Login times to the application during chemotherapy
|
Documented automatically by the application every two weeks
|
|
Average time spent on the application
大体时间：Documented automatically by the application every two weeks
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Average time spent on the application each time
|
Documented automatically by the application every two weeks
|
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Questions addressed on the Q&A platform
大体时间：Documented automatically by the application every two weeks
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Questions addressed on the Q&A platform
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Documented automatically by the application every two weeks
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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
- 研究主任：Yan Li, Doctor、Department of Breast Surgery, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
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。
一般刊物
- Wan C, Meng Q, Yang Z, Tu X, Feng C, Tang X, Zhang C. Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer. Ann Oncol. 2008 Dec;19(12):2053-60. doi: 10.1093/annonc/mdn417. Epub 2008 Jul 24.
- Cheng JX, Liu BL, Zhang X, Zhang YQ, Lin W, Wang R, Zhang YQ, Zhang HY, Xie L, Huo JL. The validation of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) in pre-operative patients with brain tumor in China. BMC Med Res Methodol. 2011 Apr 22;11:56. doi: 10.1186/1471-2288-11-56.
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 (预期的)
2022年3月7日
初级完成 (预期的)
2022年10月7日
研究完成 (预期的)
2022年12月7日
研究注册日期
首次提交
2022年2月8日
首先提交符合 QC 标准的
2022年2月16日
首次发布 (实际的)
2022年2月28日
研究记录更新
最后更新发布 (实际的)
2022年2月28日
上次提交的符合 QC 标准的更新
2022年2月16日
最后验证
2022年2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.