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临床试验/NCT00423436
NCT00423436已完成不适用

Using an Interactive Voice Response Telephone System in the Assessment and Management of Symptoms in Advanced Lung Cancer Patients Receiving Chemotherapy

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2003年4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
84
试验地点
2
主要终点
Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments

研究概览

简要总结

Primary Objectives:

  • To compare the effectiveness of an interactive voice response (IVR) telephone triage/feedback system versus an interactive voice response telephone system with assessment only in monitoring and managing symptoms in patients with advanced non small cell lung cancer (NSCLC).
  • To compare differences in mood and quality of life variables of patients using the IVR triage/feedback system versus IVR assessment only.
  • To compare the healthcare utilization (emergency visits, admissions, length of stay for hospitalizations for uncontrolled symptoms) of patients using the IVR triage/feedback system versus IVR assessment only.

详细描述

You will be asked to complete several questionnaires during a visit to the Thoracic Clinic. These questionnaires measure physical and emotional symptoms, and quality of life. Completing the questionnaires takes about 30-45 minutes. The research nurse will also teach you how to use the telephone system for reporting symptoms. You will tell the research nurse when the most convenient times for the telephone calls and the telephone system will be set up to call at those times.

It is not clear at this time whether the telephone symptom evaluation is better than the usual plan that doctors and nurses follow for asking about symptoms. For this reason, you will be randomly picked (as in the toss of a coin) to be in one of two groups. The chance of being in either one of the two programs is about equal.

Half of the patients will be assigned to the "telephone assessment system plus triage" group. If you are assigned to this group, you will report symptoms to the telephone system and the doctor or nurse at M.D. Anderson will be notified when a symptom is severe. You will also be encouraged to report all symptoms to their doctor and nurse at M.D. Anderson.

Half of the patients will be assigned to the "telephone assessment only" group. If you are assigned to this group, your symptom information will only be given through the telephone system. You will also be encouraged to report all symptoms directly to your doctor and nurse at M.D. Anderson. Your physician may request information from the telephone system.

If you are assigned to this "telephone assessment only" group, the telephone system will call you twice a week during 2 cycles of chemotherapy. It is programmed to ask you to rate your symptoms and how much the symptoms interfere in your life. Rating symptoms using the telephone system takes less than five minutes for each call.

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

入选标准

  • Patients diagnosed with stage III or IV non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) (Patients who have received other prior chemotherapy are eligible.)
  • 18 years of age or older
  • English-speaking
  • Lives in the United States
  • Adequate vision and hearing to use the Interactive Voice Response (IVR) system
  • Provides written informed consent

排除标准

  • Current diagnosis of psychosis or dementia
  • Patients unable to complete the assessment measures or unable to understand the purpose of the study

结局指标

主要结局

Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments

时间窗: Baseline to end of first chemotherapy cycle (generally chemotherapy and 1 assessment of response within 6-8 weeks)

Total number of alerts generated by symptom exceeding prespecified threshold for 7 symptoms - pain, fatigue, nausea, cough, constipation, vomiting and shortness of breath (Ratio alerts/number of assessments using IVR telephone triage/feedback versus IVR only). Reporting 0-10 severity scale of MD Anderson Symptom Inventory from 0 (symptom not present) to 10 (symptom bad as imagine it could be). Thresholds set at 4 on scale for all symptoms except shortness of breath and constipation where threshold set at 2. More than one symptom alert may appear per assessment causing ratio values to exceed 1.

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 (2)

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