跳至主要内容
临床试验/NCT01555645
NCT01555645已完成不适用

How Can Health Care Help Female Breastcancer Patients Reduce Their Stress Symptoms? A Randomized Intervention Study With Stepped-care

Uppsala University3 个研究点 分布在 1 个国家目标入组 466 人开始时间: 2009年5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
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

  1. Studying the prevalence of stress related symptoms in female patients with breast cancer
  2. Testing the use of two short screening instruments to identify women at risk for developing long-standing stress symptoms
  3. Studying the level and intensity of stress management interventions required to achieve increased well-being, using a stepped-care approach.
  4. 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

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)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验