Automated Telephone Monitoring for Symptom Management (ATSM)
研究概览
详细说明
Overview: Prevalent symptoms among patients undergoing chemotherapy include: pain, fatigue, dry mouth, constipation, anorexia, nausea, sleep disturbance, shortness of breath or difficulty breathing, as well as psychological symptoms such as depression and anxiety. A survey of 1000 patients with cancer indicated that close to a quarter reported 10-12 symptoms. Given the impact of symptoms upon physical function, work, emotional distress, and hospitalizations, it is critical that strategies be developed and tested to improve symptom management.
This trial of a behavioural intervention for symptom management is significant because: 1) it contrasts a proactive approach, individualized to patients' symptom management needs, with a more conventional model that places responsibility on the patient for symptom management; 2) it controls for the method of delivery and the use of printed material; 3) it targets prevalent symptoms known to affect cancer patients undergoing chemotherapy; 4) it examines the relative effects of each arm, in terms of symptom severity (primary outcome), impact on patients' physical and social roles, and emotional distress; and 5) it explores these outcomes in terms of their impact on the use of services and costs of care.
Goal: The goal of this randomized trial is to determine if a nurse delivered Patient Assisted Management of Symptoms (PAMS) intervention individualized to patients' needs for symptom management, delivered by telephone, when compared to Telephone Information and Monitoring of Symptoms (TIMS) where symptoms are only monitored by telephone, with references to the symptom management toolkit will reduce symptom severity, improve physical function, and other outcomes.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
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Michigan
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East Lansing、Michigan、美国、48824
- Michigan State University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 21 years of age or older
- solid tumor cancer diagnosis
- receiving chemotherapy treatment
Exclusion Criteria:
- Emotional or psychology disorder for which patient is receiving treatment
- does not speak English
- does not have access to a telephone
- difficulty hearing on the telephone
学习计划
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:护士
通过电话接受肿瘤科护士的症状管理帮助
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在 8 周内接到了 6 通肿瘤科护士打来的电话,以协助进行症状管理
|
|
实验性的:AVR
Receives symptom management assistance from an Automated telephone system
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Receives 6 telephone calls over 8 weeks from an programmed automated telephone system to assist with symptom management
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Lower reported mean severity index among 7 prevalent symptoms
大体时间:9 weeks, 15 weeks
|
9 weeks, 15 weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Reduced impact of physical role performance, improved social functioning, and reduced emotional distress; improved levels of communication between patients and providers; and improved patient satisfaction with care.
大体时间:9 weeks, 15 weeks
|
9 weeks, 15 weeks
|
合作者和调查者
调查人员
- 首席研究员:Charles Given, PhD、Michigan State University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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