Individually Tailored Rehabilitation After Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 2
- 主要终点
- Distress
研究概览
简要总结
The aim of the study is to evaluate whether a screening-based individually tailored nurse navigator intervention compared to standard care significantly reduce psychological and physical symptoms among women being treated for breast cancer who had moderate-to-severe distress (score ≥ 7 on the distress thermometer).
详细描述
During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324 participants enter the randomized controlled trial (RCT) and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care). A total of 432 participants will enter an observational questionnaire study. All participants are followed for 1,5 years.
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 (Outcomes Assessor)
盲法说明
Intervention status will be blinded in analyses.
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
- •Newly diagnosed with breast cancer (i.e. prior to surgery), scheduled for breast cancer surgery at Section of Breast Surgery at Rigshospitalet, 18 years or above, Danish citizen, read, understand and speak Danish, female gender,signed written informed consent. Those who experience high psychological distress (score ≥ 7 on the distress thermometer) will enter the RCT whereas those who experience low psychological distress (score < 7 on the distress thermometer) will be followed in an observational questionnaire study.
排除标准
- •no severe cognitive problems or dementia, no severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence,
结局指标
主要结局
Distress
时间窗: Change from baseline and to 6,12 months (mixed models)
Distress Thermometer
次要结局
- Acceptability(18 months)
- Health related quality of life summary index(Change from baseline and to 18 months)
- Anxiety(Change from baseline and to 18 months)
- Neuropathy in the breast surgery area (side of chest, armpit or arm)(Change from baseline and to 18 months)
- Distress(Change from baseline to 18 months)
- Breast cancer related quality of life summary index(Change from baseline and to 18 months)
- Functional related quality of life summary index(Change from baseline and to 18 months)
- Fear of recurrence(18 months)
- Pain in the breast surgery area (side of chest, armpit or arm)(Change from baseline and to 18 months)
- Cognitive function - Perceived cognitive impairments(Change from baseline and to 18 months)
- Depression(Change from baseline and to 18 months)
- Physical health related quality of life(Change from baseline and to 18 months)
- Social health related quality of life(Change from baseline and to 18 months)
- Emotional health related quality of life(Change from baseline and to 18 months)
- Cognitive function- Perceived cognitive impairments(Change from baseline and to 12 months)
- Self-efficacy(Change from baseline and to 18 months)
- Sleep quality(Change from baseline and to 18 months)
- Cognitive function - Perceived cognitive abilities(Change from baseline and to 18 months)
- Health care costs(Cumulative from baseline to 18 months)
- Cognitive function - Impact of Perceived cognitive impairments on quality of life(Change from baseline and to 18 months)
- Need for support(Change from baseline and to 18 months)
研究者
Christoffer Johansen
Professor, DMSc
Danish Cancer Society