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临床试验/NCT01979146
NCT01979146已完成不适用

Telephone Linked Care for Cancer Symptom Management

University of Utah6 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2001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
250
试验地点
6
主要终点
Patient reported symptom levels on a 0-10 scale

研究概览

简要总结

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.

详细描述

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

  • 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

排除标准

  • 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

结局指标

主要结局

Patient reported symptom levels on a 0-10 scale

时间窗: patients report symptoms daily for the duration of the study, an expected average of 6 weeks

During daily automated calls, patients provided information about common chemotherapy symptoms.

次要结局

  • Medical Encounters Telephone Interview(participants will be followed for an expected average of 6 weeks)
  • Work Attendance(reported daily, participants will be followed for an expected average of 6 weeks)
  • Functional Status(monthly for the duration of the study, participants will be followed for an expected average of 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Mooney

Principal Investigator

University of Utah

研究点 (6)

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