How Can Health Care Help Female Breastcancer Patients Reduce Their Stress Symptoms? A Randomized Intervention Study With Stepped-care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 466
- 试验地点
- 3
- 主要终点
- Psychosocial aspect
研究概览
简要总结
The purpose of this study within Caring sciences is to identify women with breast cancer who have stress symptoms and to offer these women appropriate care to reduce stress and increase well-being. This will be achieved by
- Studying the prevalence of stress related symptoms in female patients with breast cancer
- Testing the use of two short screening instruments to identify women at risk for developing long-standing stress symptoms
- Studying the level and intensity of stress management interventions required to achieve increased well-being, using a stepped-care approach.
- Studying the effects of interventions based on cognitive behavior therapy, delivered individually or in a group format.
The hypothesis is that half of the individuals assigned to a low intensity intervention will be significantly improved after treatment. For individuals who continue to have symptoms after low intensity treatment it is hypothesized that continued treatment in a group setting with high intensity interventions will be more cost-effective. In addition the assumption is that reduction of stress symptoms in women with breast cancer will lead to a reduction in socio-economic costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •over the age of 18
- •a recent diagnosis of breast cancer
- •scheduled for adjuvant treatment in Falun, Gävle or Uppsala (Sweden)
排除标准
- •ongoing psychiatric condition
- •language deficiencies in Swedish
结局指标
主要结局
Psychosocial aspect
时间窗: Changes in psychosocial aspects from baseline to 12 months post diagnosis
Intrusion, Avoidance, Anxiety, Depression, Quality of life, Fatigue, Daily stress
次要结局
- Cost-Utility Analysis(12 month)
- Patient satisfaction(3 month, after intensive intervention and 12 month)
