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临床试验/NCT00760305
NCT00760305已完成不适用

Pro-self - a Nursing Intervention to Support and Educate Cancer Patients and Their Caregivers so That the Patient Can Stay Home

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2004年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
167
试验地点
1
主要终点
Worst pain intensity

研究概览

简要总结

The main aim of this study is to evaluate whether a patient education programme on cancer pain management compared to standard care decreases pain and increases patients quality of life. The investigators hypothesis is that patients and family caregivers who receive the intervention will have improved outcomes. Patients and family members are seen in their homes by the nurses doing the intervention over 6 weeks. Patients keep a diary of their pain and medication intake.

详细描述

The undertreatment of cancer pain remains a significant clinical problem. The PRO-SELF Pain Control Program is a 6 week psychoeducational intervention that was shown to improve pain management in oncology outpatients with pain from bone metastasis. However, this promising intervention requires replication in samples of oncology patients with cancer pain outside of the United States.

The purpose of the study was to test the effectiveness of The PRO-SELF Pain Control Program in Norwegian cancer patients and their family caregivers. Only data on patient outcomes will be presented.

The theoretical framework for this study incorporated elements of Orem's self-care theory, as well as the principles of academic detailing and nurse coaching to change patients' self-care behaviors regarding cancer pain management.

Two hundred adult cancer patients with pain from skeletal metastasis and their caregivers participated in this study. Patients were randomized to either the PRO-SELF program or standard care. Patients completed questionnaires about pain, physical functioning, quality of life, anxiety, and depression at the time of enrollment and after 6 weeks. Data on analgesics were collected through chart reviews and patient diaries. Both groups received home visits and telephone calls by an oncology nurse over a period of six weeks. Participants in the intervention group received education about pain management and were coached to improve their pain management behaviors. Two-way repeated measures analyses of variance will be done to determine differences in pain intensity scores and to evaluate the differences over time in the total amount of opioid analgesics taken by the patients.

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
Single (Participant)

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

  • Greater than 18 years of age
  • Radiographic evidence of bone metastasis
  • Able to read and write Norwegian
  • Average pain intensity of greater than 2.5

排除标准

  • Brain metastasis

结局指标

主要结局

Worst pain intensity

时间窗: 6 weeks

次要结局

  • Knowledge of cancer pain management(6 weeks)

研究者

发起方
Oslo University Hospital
申办方类型
Other

研究点 (1)

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Pro-self Pain Management in Norway | 临床试验