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临床试验/NCT00881010
NCT00881010已完成不适用

Automated Pain Intervention for Underserved Minority Breast Cancer Patients

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
MDASI IVR Patient Symptom Assessment

研究概览

简要总结

The goal of this psychosocial research study is to learn about treating pain and other symptoms of minority patients who have breast cancer. The study will test how well a special telephone system works for improving the pain and symptom management of these patients.

详细描述

The special telephone system used in this study calls patients on a regular basis and asks them to report their symptoms. The patient's doctor or nurse is notified by a page or e-mail when one or more of these symptoms is severe: pain, shortness of breath, nausea, vomiting, drowsiness, sadness, and emotional distress. Researchers want to find out if using the telephone system is a better way to manage a patient's pain and symptoms than the normal method, in which the doctor and nurse would simply ask about pain and other symptoms.

You will be asked to complete several questionnaires during a visit to the oncology clinic. These questionnaires measure pain and other symptoms, quality of life, and mood. Completing the questionnaires takes about 1 hour. These will be completed during your first study visit (called the "baseline" visit.)

If you choose to take part in this study, you will be randomly assigned (as in the toss of a coin) to receive 1 of 2 treatment plans: telephone intervention or usual care. You have an equal chance of being assigned to either group.

If you are picked to be in the "telephone intervention" group, the research nurse will teach you how to use the telephone system for measuring symptoms. The research nurse also will ask you to practice using the telephone system. The telephone system will call you 2 times a week for 10 weeks and ask you to rate your pain and other symptoms and how much the symptoms interfere with your life. You can set up the most convenient times for the telephone calls. Rating your symptoms using the telephone system takes less than 5 minutes for each call.

Your symptom information from the telephone system will be given to your doctor and nurse at M. D. Anderson. The doctor or nurse will be notified right away by page or e-mail when one or more of these symptoms is severe: pain, shortness of breath, nausea, vomiting, drowsiness, sadness, and emotional distress. Patients in this group will also receive education from the telephone system about pain and pain treatments. If for some reason the telephone system is not working, the research staff will report your severe symptoms to your doctor of nurse, and give you the education about pain and pain treatments.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of breast cancer
  • African American or Hispanic female
  • Receiving treatment at LBJ General Hospital, Ben Taub Hospital, or M.D. Anderson Cancer Center
  • Socioeconomically disadvantaged, as indicated by hospital billing code
  • 18 years of age or older
  • Living in the United States
  • Speaks English or Spanish
  • "Pain worst" score of 4 or greater on the Brief Pain Inventory

排除标准

  • Current diagnosis of psychosis or dementia
  • No access to telephones
  • Unable to use the IVR system due to physical limitations (e.g., hearing impairment)

结局指标

主要结局

MDASI IVR Patient Symptom Assessment

时间窗: Twice weekly

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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