Self-management Support in Cancer Pain
2015年1月7日 更新者：Maastricht University Medical Center
Effects of a Multifaceted Teleguided Pain Care Program in Patients With Cancer Pain
Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life.
Integration of patient self-management and professional care by means of care technology provides new opportunities in the outpatient setting.
In this project a technology based and nurse delivered multicomponent self-management support intervention has been developed.
Important components include monitoring, feedback, education, and nurse support.
Following feasibility evaluation, the primary aim of this randomized controlled trial is to assess the effect of the intervention regarding pain intensity and quality of life as compared to care as usual.
Secondary outcomes of the effect evaluation are self-efficacy, knowledge, anxiety and depression, and pain medication use.
Besides, a cost-evaluation and summative process evaluation will be performed.
研究概览
研究类型
介入性
注册 (预期的)
174
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
-
-
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Heerlen、荷兰
- 招聘中
- Atrium Medical Center
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接触：
- Asiong Jie, MD, PhD
- 电话号码：+31 455766666
- 邮箱：G.Jie@atriummc.nl
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Maastricht、荷兰
- 招聘中
- Maastricht University Medical Center
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接触：
- Annemie Courtens, PhD
- 电话号码：+31 433877548
- 邮箱：a.courtens@mumc.nl
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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:
- Diagnosis of cancer
- Patients who are under (palliative) anti-tumour treatment in a day clinic or outpatient clinic, or patients who have no treatment options available anymore
- Cancer (treatment related) pain > 2 weeks
- Pain is defined as a patient reported pain score of 4 or more on a numerical rating scale (scale 0-10)
- Living at home
Exclusion Criteria:
- Expected life expectancy < 3 months
- Chronic non-cancer pain
- Known cognitive impairments
- Participation in other studies that interfere with this study
- Not being able to read and understand the Dutch language
- Reduced vision
- Non-reachable by phone
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制组
一如既往的关怀
|
|
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实验性的：Intervention group
Self-management support
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The 12-week intervention consists of an iPad application for patients that is connected to a web application for nurses.
Every morning and evening patients register pain and related symptoms by use of a pain diary.
Patients are also requested to register medication intake.
Graphical feedback is provided based on registered pain scores and medication intakes.
Patients receive education on causes and treatment of pain, symptoms that require action, and methods to better control pain.
Patients communicate with nurses via text message functionality within the application.
Specialized nurses remotely monitor and analyze the patients' situation once every workday.
Nurses have the opportunity to collaborate with the treating physician, pain specialist or multidisciplinary team.
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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 intensity (Brief Pain Inventory - Short Form (BPI-SF)
大体时间：12 weeks
|
As measured with the Brief Pain Inventory - Short Form (BPI-SF)
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12 weeks
|
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Change in cancer related quality of life (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
大体时间：12 weeks
|
As measured with the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
|
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS)
大体时间：12 weeks
|
As measured with the Chronic Pain Self-efficacy Scale (CPSS)
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12 weeks
|
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Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ)
大体时间：12 weeks
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As measured with the Pain Knowledge Questionnaire (PKQ)
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12 weeks
|
|
Change in anxiety and depression (Hospital Anxiety and Depression Scale (HADS)
大体时间：12 weeks
|
As measured with the Hospital Anxiety and Depression Scale (HADS)
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12 weeks
|
|
Change in pain medication use (Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview)
大体时间：12 weeks
|
As measured with the Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview
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12 weeks
|
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。
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
2014年2月1日
初级完成 (预期的)
2015年6月1日
研究完成 (预期的)
2015年8月1日
研究注册日期
首次提交
2014年12月29日
首先提交符合 QC 标准的
2015年1月7日
首次发布 (估计)
2015年1月8日
研究记录更新
最后更新发布 (估计)
2015年1月8日
上次提交的符合 QC 标准的更新
2015年1月7日
最后验证
2015年1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.
Self-management support的临床试验
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National... 和其他合作者完全的
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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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Women's College HospitalRyerson University撤销