Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness During Radiotherapy (RT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- Change in Pain intensity
研究概览
简要总结
The purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer.
详细描述
The purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer
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
盲法说明
All patients who referred to the Pain and Rehabilitation Centre at the University Hospital, asked about participation in the study. Of those who agreed to participate every second patient were distributed to the control group versus intervention group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All HNC patients who went through RT and were referred to the Pain and Rehabilitation Centre at the University Hospital (Linköping, Sweden) were invited to participate in the study which run from January 2015 - March
排除标准
- •Non Swedish speaking individuals, severe social and/or psychological disorders, severe cognitive conditions,other serious medical conditions.
结局指标
主要结局
Change in Pain intensity
时间窗: Change from baseline pain intensity at 20 weeks
Pain intensity the actual day using a numeric rating scale.
Change in Pain Interference
时间窗: Change from baseline pain interference at 20 weeks
Pain interference the actual day using a numeric rating scale
Change in Perceived health index
时间窗: Change from baseline EQ-5D index at 20 weeks
Perceived health according to the index based on five dimensions of European Quality of Life instrument (EQ-5D index)
Change in Perceived health scale
时间窗: Change from baseline EQ-VAS at 20 weeks
Perceived health according to the visual analgue scale of European Quality of Life instrument (EQ-VAS)
次要结局
- Change in depression(Change from baseline depression at 20 weeks)
- Change in anxiety(Change from baseline anxiety at 20 weeks)
- Change in catastrophizing(Change from baseline catastrophizing at 20 weeks)
研究者
Bjorn Gerdle
Professor MD
Linkoeping University