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临床试验/NCT01973946
NCT01973946已完成不适用

Telephone Linked Care: An IT Enabled Integrated System for Cancer Symptom Relief

University of Utah4 个研究点 分布在 1 个国家目标入组 358 人开始时间: 2007年9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
358
试验地点
4
主要终点
Patient reported symptom levels

研究概览

简要总结

The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for symptom concerns.

详细描述

The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for symptom concerns. For the intervention group, the monitoring system is paired with automated delivery of self-care suggestions tailored to the specific symptom profile the patient reported and also automatically 'alerts' the study oncology nurse practitioner about unrelieved symptoms. The nurse practitioner, utilizing national evidence based symptom guidelines for symptoms at moderate to severe levels calls the patient and further assesses and intensifies symptom treatment. The usual care group called the system daily and reported similar data but did not receive self-care coaching or notification of unrelieved symptoms to the study nurse practitioner. On every call, the usual care group was told to follow the standard procedure of calling their oncology providers for symptom concerns. The specific aims of the study are to test whether the symptom monitoring intervention reduces presence, severity and distress of 11 symptoms. The symptoms monitored in the project were nausea/vomiting, pain, sore mouth, numbness & tingling, diarrhea, trouble thinking, trouble sleeping, changes in appearance, depressed mood, anxiety, and fatigue. Secondary outcomes tested whether the intervention improved functional performance and decreased interference with activity when compared with the usual care attentional control group. Other aims compare self care strategies utilized and their perceived effectiveness and document patient satisfaction with the monitoring system.

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 (age 18 or over)
  • Have a histological diagnosis of cancer
  • a life expectancy of at least 3 months and cognitively able to participate
  • Beginning a new course of chemotherapy that is planned for a minimum of 3 cycles;
  • care is under the direction of one of the 8 designated provider teams;
  • English speaking;
  • has access to a telephone on a daily basis and is able to use the phone unassisted as verified by the study staff during participant orientation.

排除标准

  • patients who are receiving concurrent radiation therapy (as they would have daily contact with the health care system);
  • patients who see the provider team for recommendation of a chemotherapy regimen but treatment is then administered at a different site by other providers.
  • Patients receiving therapy agents that result in a drug related fever or therapy agents that are not anticipated to cause any of the 11 symptoms.

结局指标

主要结局

Patient reported symptom levels

时间窗: Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.

During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.

次要结局

  • Medical Encounters Telephone Interview(Each week patients reported during the daily symptom monitoring call whether they had a medical encounter for an entire new course of chemotherapy or 6 months whichever occurred first.)
  • Patient reported symptom related interference with daily activities(Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.)
  • SF-36 Functional Status(Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.)
  • Work interference(Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.)
  • Work Limitations Questionnaire(Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.)

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 (4)

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