Automated Telephone Monitoring for Symptom Management
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 526
- 试验地点
- 2
- 主要终点
- Lower reported mean severity index among 7 prevalent symptoms
研究概览
简要总结
To improve the management of symptoms, patients with cancer undergoing chemotherapy will be monitored using an automated telephone system to record the severity of 15 prevalent symptoms for up to 8 consecutive weeks. Outcomes include; significant reduction in symptom severity and improvement in health states.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years of age or older
- •solid tumor cancer diagnosis
- •receiving chemotherapy treatment
排除标准
- •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
结局指标
主要结局
Lower reported mean severity index among 7 prevalent symptoms
时间窗: 9 weeks, 15 weeks
次要结局
- 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.(9 weeks, 15 weeks)
研究者
Bill Given
Professor
Michigan State University
