Cancer Symptom Monitoring Telephone System With Nurse Practitioner (NP) Follow up
2017年2月28日 更新者：Kathleen Mooney、University of Utah
Telephone Linked Care: An IT Enabled Integrated System for Cancer Symptom Relief
The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for symptom concerns.
研究概览
详细说明
The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for symptom concerns.
For the intervention group, the monitoring system is paired with automated delivery of self-care suggestions tailored to the specific symptom profile the patient reported and also automatically 'alerts' the study oncology nurse practitioner about unrelieved symptoms.
The nurse practitioner, utilizing national evidence based symptom guidelines for symptoms at moderate to severe levels calls the patient and further assesses and intensifies symptom treatment.
The usual care group called the system daily and reported similar data but did not receive self-care coaching or notification of unrelieved symptoms to the study nurse practitioner.
On every call, the usual care group was told to follow the standard procedure of calling their oncology providers for symptom concerns.
The specific aims of the study are to test whether the symptom monitoring intervention reduces presence, severity and distress of 11 symptoms.
The symptoms monitored in the project were nausea/vomiting, pain, sore mouth, numbness & tingling, diarrhea, trouble thinking, trouble sleeping, changes in appearance, depressed mood, anxiety, and fatigue.
Secondary outcomes tested whether the intervention improved functional performance and decreased interference with activity when compared with the usual care attentional control group.
Other aims compare self care strategies utilized and their perceived effectiveness and document patient satisfaction with the monitoring system.
研究类型
介入性
注册 (实际的)
358
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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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt-Ingram Cancer Center
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Utah
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Salt Lake City、Utah、美国、84132
- University of Utah Huntsman Cancer Institute
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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:
- Adult (age 18 or over)
- Have a histological diagnosis of cancer
- a life expectancy of at least 3 months and cognitively able to participate
- Beginning a new course of chemotherapy that is planned for a minimum of 3 cycles;
- care is under the direction of one of the 8 designated provider teams;
- English speaking;
- has access to a telephone on a daily basis and is able to use the phone unassisted as verified by the study staff during participant orientation.
Exclusion Criteria:
- patients who are receiving concurrent radiation therapy (as they would have daily contact with the health care system);
- patients who see the provider team for recommendation of a chemotherapy regimen but treatment is then administered at a different site by other providers.
- Patients receiving therapy agents that result in a drug related fever or therapy agents that are not anticipated to cause any of the 11 symptoms.
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 |
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无干预：Usual Care
Patients in the usual care group called the automated monitoring system daily to report presence, severity, and distress for 11 common symptoms.
The attentional control group received equivalent contact time with the automated system including identical voice and assessment questions.
Patients did not hear self-care messages during the call and the data were not available for clinical action by the study nurse practitioner.
Patients were told on every phone call to call their oncology providers if they had concerns about their symptoms which is usual care for symptom follow up in oncology.
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实验性的：Symptom Alert and Coaching
Patients in the Symptom Alert and Coaching arm called the automated monitoring system daily to report presence, severity, and distress on 11 symptoms. The system provided automated self care coaching based on the symptoms reported and automatically generated alerts to the study NP if symptoms exceeded preset thresholds. Two thresholds were set: a simple alert when severity or distress was 4 or greater on a 10 point scale and trend alerts based on a pattern of moderate severity over several days. The alerts went into a case management site. The study NP logged into the system daily and responded to the alerts within 24 hours by calling patients to further assess the symptoms and to intensify symptom treatment using evidence based guidelines. |
Patients heard self-care messages when they reported a symptom was present.
The Symptom Alert and Coaching intervention alerted study nurse practitioners of unresolved symptoms daily.
The NPs responded to all alerts generated by patients and using evidence based guidelines, called patients to further assess and to intensify symptom treatment.
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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 |
|---|---|---|
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Patient reported symptom levels
大体时间：Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.
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During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.
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Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Medical Encounters Telephone Interview
大体时间：Each week patients reported during the daily symptom monitoring call whether they had a medical encounter for an entire new course of chemotherapy or 6 months whichever occurred first.
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Each week patients reported during their daily phone calls whether or not they had been in contact with a health care provider, were seen in an emergency department or urgent care facility, or had an unscheduled hospitalization.
If they reported they did have a medical encounter, the research staff would call and conduct a short telephone interview to collect data about the nature of the medical encounter including whether the medical encounter was related to the symptoms being monitored.
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Each week patients reported during the daily symptom monitoring call whether they had a medical encounter for an entire new course of chemotherapy or 6 months whichever occurred first.
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Patient reported symptom related interference with daily activities
大体时间：Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
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This is a one item question asked daily during the symptom monitoring call about the level of interference their symptoms had on their daily activities (0-10 scale).
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Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
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SF-36 Functional Status
大体时间：Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
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Functional status was measured monthly using the SF-36.
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Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
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Work interference
大体时间：Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
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For patients who indicated they worked during their treatment, the system asked daily if they missed work if it was a regular workday.
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Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
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Work Limitations Questionnaire
大体时间：Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
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The 25 item patient-reported Work Limitations Questionnaire was used to measure work performance.
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Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient End of Study Telephone Interview
大体时间：Administered once, at the end of the patients' participation in the study which was following an entire new course of chemotherapy or 6 months whichever occurred first.
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An End of Study Telephone Interview was conducted at the end of a patient's participation in the project to obtain data on patient satisfaction with the symptom monitoring system and to obtain suggestions for improvement of the system.
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Administered once, at the end of the patients' participation in the study which was following an entire new course of chemotherapy or 6 months whichever occurred first.
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Evaluation of automated and other self care strategies used and their effectiveness
大体时间：Weekly for an entire new course of chemotherapy or 6 months whichever occurred first.
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The symptom monitoring system tracked when an intervention participant heard a self care strategy during the course of the week.
Each week patients would report on how helpful (1-10 scale) the automated self care measures were for the specific symptoms.
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Weekly for an entire new course of chemotherapy or 6 months whichever occurred first.
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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
- 首席研究员：Kathleen H Mooney, PhD、University of Utah
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
2007年9月1日
初级完成 (实际的)
2012年4月1日
研究完成 (实际的)
2012年4月1日
研究注册日期
首次提交
2013年10月22日
首先提交符合 QC 标准的
2013年10月25日
首次发布 (估计)
2013年11月1日
研究记录更新
最后更新发布 (实际的)
2017年3月1日
上次提交的符合 QC 标准的更新
2017年2月28日
最后验证
2017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.