Using Mini Program for Self-management VS Conventional Pharmaceutical Care for Cancer Pain
2021年4月13日 更新者：Fujian Cancer Hospital
Comparison of Cancer Pain Patients With or Without Mini Program
With the existing medical system and insufficient medical resources in China, we developed a mini program.
a pain management mini app can be useful and appreciated by patients and health care professionals, making it a good choice for the management of cancer pain in our country .
our study want to develop and test the mini program for pain management among Chinese cancer patients in or discharged from hospital treatment.
研究概览
详细说明
Healthcare interventions delivered via personal mobile device have been shown to be acceptable to users, who have identified benefits such as convenience, access to personalized information, greater awareness of own health. Integrating mini program into the cancer pain care may be an effective strategy to improve cancer pain patients self-management.
To design, construct, and test the mini program in patients managing cancer pain, evaluate the total remission rate of pain and the improvement in medicine compliance to improve pain management for cancer pain patients, and assess patient acceptance of the mini program.
研究类型
介入性
注册 (预期的)
200
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：QiuLing Zhao
- 电话号码：5305 0591-83660063
- 邮箱：qlzhao8@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
- 孩子
- 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:
- Patients aged 18 years or older;
- Be able to read Chinese and use a mobile phone;
- Histologically or cytologically confirmed solid tumor;
- Diagnosed chronic cancer pain
- Could understand the study process and evaluation, agreed to participate in the trial, and signed the informed consent form.
Exclusion Criteria:
- Illiterate person;
- Incompetence;
- Inability to complete the pain assessment;
- Participation in any other therapies or other study protocols that may have an impact on pain intensity, which were the main outcomes of this study;
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：a mini program trial group
Pharmacists conducted a standardized education session to teach the participants how to operate the mobile phone, use mini program, assess pain.
The participants in the trial group were asked to complete initial and final pain assessment questionnaires and Medication compliance on the mobile phones provided to them.
Participants were encouraged to use mini program as much as possible to record their pain status.
|
To design, construct, and test the mini program in patients managing cancer pain
其他名称：
|
|
假比较器：a control group
The control group received conventional pharmaceutical care.
Initial and final pain and Medication compliance data were collected.
Before the patient was discharged from the hospital, the clinical pharmacist conducted detailed medication education (including medication methods, prevention and treatment of adverse reactions, and precautions) and asked the patient to attempt to maintain a paper version of the pain diary.
|
conventional pharmaceutical care
|
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 in pain score
大体时间：Change from baseline at four weeks after discharge
|
Comparison of pain score of cancer pain patients with or without mini program.
Pain score will be assessed by using numeric rating scale (NRS).
An NRS allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be."
|
Change from baseline at four weeks after discharge
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in medication adherence
大体时间：Change from baseline at four weeks after discharge
|
The investigators will measure the change in medication adherence via Morisky Scale.
Morisky Scale contains 4 questions, and the total score ranges from 0 to 4 with lower scores indicating higher adherence.
|
Change from baseline at four weeks after discharge
|
|
Incidence of adverse events
大体时间：Up to four weeks after discharge
|
Adverse events will be assessed throughout the study according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0.
Number of subjects who experienced an adverse event in this study is presented.
|
Up to four weeks after discharge
|
|
Change in quality of life
大体时间：Change from baseline at four weeks after discharge
|
Comparison of quality of life of cancer pain patients with or without mini program.
Quality of life is assessed using EuroQol- 5 Dimension (EQ-5D).
|
Change from baseline at four weeks after discharge
|
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 (预期的)
2021年5月1日
初级完成 (预期的)
2021年5月30日
研究完成 (预期的)
2021年6月1日
研究注册日期
首次提交
2021年4月8日
首先提交符合 QC 标准的
2021年4月13日
首次发布 (实际的)
2021年4月14日
研究记录更新
最后更新发布 (实际的)
2021年4月14日
上次提交的符合 QC 标准的更新
2021年4月13日
最后验证
2021年4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
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.