Cancer & Chemotherapy Symptom Management Using an Automated Telephone Reporting System
2017年2月28日 更新者：Kathleen Mooney、University of Utah
Telephone Linked Care for Cancer Symptom Management
The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers.
研究概览
详细说明
The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers.
The symptoms monitored in the project were nausea/vomiting, pain, sore mouth, diarrhea, constipation, depressed mood, anxiety, trouble sleeping, and fatigue.
The study randomly assigned participants into either the intervention group or the group that received usual care from their oncology providers without alert notifications.
All participants called the automated system daily to report their symptom presence, severity, and distress.
When participants in the intervention group rated symptoms at moderate (4-7) to severe (8-10) levels an e-mail alert report of their symptom information was sent to the participant's medical oncologist and oncology nurse.
The usual care group also reported symptoms daily to the automated system but their information was not sent to the providers.
Participants in the usual care group were told daily to call their oncology provider if they had concerns about their symptoms.
The two study groups were compared over chemotherapy cycles 2 and 3 on symptom presence, severity, and distress.
Functional status, patient reported degree of symptom interference with normal activities, and work attendance if they had indicated that they worked during their treatment were also recorded.
In addition, the groups were compared for the number and purpose of unscheduled patient-provider contacts, visits to the emergency department or urgent care facility, and unscheduled hospitalizations.
研究类型
介入性
注册 (实际的)
250
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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Massachusetts
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Boston、Massachusetts、美国、02118
- Boston Medical Center
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South Carolina
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Greer、South Carolina、美国、29650
- South Carolina Community Oncology Practice
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Utah
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Salt Lake City、Utah、美国、84112
- 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 (18 or older)
- Histological Diagnosis of Cancer
- Life Expectancy of at least 6 months
- Cognitively able to participate (verified by provider team)
- Initiated a course of new Chemotherapy that is planned for a minimum of 3 cycles
- Had Poorly controlled symptoms during the first cycle of chemotherapy
- Care under the direction of one of the designated provider teams
- English or Spanish speaking
- Has access to a telephone on a daily basis
- Able to use the telephone unassisted
Exclusion Criteria:
- Receiving concurrent radiation therapy because they would be in daily contact with oncology care providers.
- Patients seeing the provider team for recommendation of chemotherapy regimen but other providers then administer treatment at different site
- Patients receiving a treatment regimen with only biotherapy agents or agents not associated with the symptoms monitored
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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实验性的：Provider Unrelieved Symptom Alert
Patients in the intervention arm called the automated monitoring system daily to report presence, severity and distress on a 1-10 scale for nine symptoms.
The system immediately sent an emailed symptom alert report to their oncologist and oncology nurse if symptoms exceeded preset thresholds (moderate to severe levels).
Two thresholds were set: a simple alert when severity or distress was 4 or greater on the 10 point scale and trend alerts based on a pattern of moderate severity over several days.
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The Provider Unrelieved Symptom Alert intervention sent an automatic symptom report to oncology providers (both physician and nurse) when the patient reported symptoms at a moderate to severe level (4-10 on a 0-10 scale).
The oncology providers used their clinical judgement in terms of what they did with the information received.
There was no prescribed response as part of the intervention.
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无干预：Attentional Control Usual Care Group
Patients in the usual care group called the automated monitoring system daily to report presence, severity and distress (1-10 scale) on 9 symptoms and also measured symptom interference with daily activities, functional status, work attendance, and unscheduled provider visits, urgent care and emergency department visits, and unscheduled hospitalizations.
The usual care group received equivalent contact time with the automated system including identical voice and assessment questions.
Data were not available for clinical action and not reported to the oncology providers.
On every call, usual care participants were reminded to call their oncology provider if they had symptom concerns, which is the usual practice in oncology settings to address unrelieved symptoms.
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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 on a 0-10 scale
大体时间：patients report symptoms daily for the duration of the study, an expected average of 6 weeks
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During daily automated calls, patients provided information about common chemotherapy symptoms.
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patients report symptoms daily for the duration of the study, an expected average of 6 weeks
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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：participants will be followed for an expected average of 6 weeks
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When a patient reports during their daily phone call with the automated symptom monitoring system that they had been in contact with a health care provider, the research staff would 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 by the system.
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participants will be followed for an expected average of 6 weeks
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Functional Status
大体时间：monthly for the duration of the study, participants will be followed for an expected average of 6 weeks
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The SF-12 was administered monthly to measure functional status.
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monthly for the duration of the study, participants will be followed for an expected average of 6 weeks
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Work Attendance
大体时间：reported daily, participants will be followed for an expected average of 6 weeks
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Patients who indicated at study enrollment that they planned to work during treatment answered a yes/no question during the automated symptom monitoring system call to report whether or not they worked the previous day.
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reported daily, participants will be followed for an expected average of 6 weeks
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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 at the end of participation in the study, participants will be followed for an expected average of 6 weeks
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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 at the end of participation in the study, participants will be followed for an expected average of 6 weeks
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Provider End of Study Interview
大体时间：Once, at the end of participation which is an expected average of 24 months
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At the end of the study, participating providers were interviewed regarding the acceptability and use of the symptom alert reports and their suggestions for improvement.
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Once, at the end of participation which is an expected average of 24 months
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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
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
2001年4月1日
初级完成 (实际的)
2004年3月1日
研究完成 (实际的)
2004年3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11月1日
首次发布 (估计)
2013年11月8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.