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临床试验/NCT03254875
NCT03254875已完成不适用

Individually Tailored Rehabilitation After Breast Cancer

Danish Cancer Society1 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2017年8月15日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
309
试验地点
1
主要终点
Distress
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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,

研究组 & 干预措施

Intervention

Experimental

Individually tailored nurse navigation

干预措施: Individually tailored nurse navigation (Behavioral)

Control

No Intervention

Usual care

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

  • Social health related quality of life(Change from baseline and to 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)
  • 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)
  • 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)
  • Health care costs(Cumulative from baseline to 18 months)
  • Acceptability(18 months)
  • Distress(Change from baseline to 6 months)
  • Distress(Change from baseline to 12 months)
  • Depression(Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models))
  • Depression(Change from baseline and to 6 months)
  • Depression(Change from baseline and to 12 months)
  • Anxiety(Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models))
  • Anxiety(Change from baseline and to 6 months)
  • Anxiety(Change from baseline and to 12 months)
  • Health related quality of life summary index(Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models))
  • Health related quality of life summary index(Change from baseline and to 6 months)
  • Health related quality of life summary index(Change from baseline and to 12 months)
  • Breast cancer related quality of life summary index(Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models))
  • Breast cancer related quality of life summary index(Change from baseline and to 6 months)
  • Breast cancer related quality of life summary index(Change from baseline and to 12 months)
  • Functional related quality of life summary index(Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models))
  • Functional related quality of life summary index(Change from baseline and to 6 months)
  • Functional related quality of life summary index(Change from baseline and to 12 months)
  • Physical health related quality of life(Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models))
  • Physical health related quality of life(Change from baseline and to 6 months)
  • Physical health related quality of life(Change from baseline and to 12 months)
  • Social health related quality of life(Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models))
  • Social health related quality of life(Change from baseline and to 6 months)
  • Social health related quality of life(Change from baseline and to 12 months)
  • Emotional health related quality of life(Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models))
  • Emotional health related quality of life(Change from baseline and to 6 months)
  • Emotional health related quality of life(Change from baseline and to 12 months)
  • Self-efficacy(Change from baseline and to 6,12,18 months (mixed models))
  • Self-efficacy(Change from baseline and to 6 months)
  • Self-efficacy(Change from baseline and to 12 months)
  • Fear of recurrence(6 months)
  • Fear of recurrence(12 months)
  • Pain in the breast surgery area (side of chest, armpit or arm)(Change from baseline and to 6,12,18 months (mixed models))
  • Pain in the breast surgery area (side of chest, armpit or arm)(Change from baseline and to 6 months)
  • Pain in the breast surgery area (side of chest, armpit or arm)(Change from baseline and to 12 months)
  • Neuropathy in the breast surgery area (side of chest, armpit or arm)(Change from baseline and to 6,12,18 months (mixed models))
  • Neuropathy in the breast surgery area (side of chest, armpit or arm)(Change from baseline and to 6 months)
  • Neuropathy in the breast surgery area (side of chest, armpit or arm)(Change from baseline and to 12 months)
  • Sleep quality(Change from baseline and to 6,12,18 months (mixed models))
  • Sleep quality(Change from baseline and to 6 months)
  • Sleep quality(Change from baseline and to 12 months)
  • Cognitive function - Perceived cognitive impairments(Change from baseline and to 6,12,18 months (mixed models))
  • Cognitive function - Perceived cognitive impairments(Change from baseline and to 6 months)
  • Cognitive function - Impact of Perceived cognitive impairments on quality of life(Change from baseline and to 6,12,18 months (mixed models))
  • Cognitive function - Impact of Perceived cognitive impairments on quality of life(Change from baseline and to 6 months)
  • Cognitive function - Impact of Perceived cognitive impairments on quality of life(Change from baseline and to 12 months)
  • Cognitive function - Perceived cognitive abilities(Change from baseline and to 6,12,18 months (mixed models))
  • Cognitive function - Perceived cognitive abilities(Change from baseline and to 6 months)
  • Cognitive function - Perceived cognitive abilities(Change from baseline and to 12 months)
  • Need for support(Change from baseline and to 6,12,18 months (mixed models))
  • Need for support(Change from baseline and to 6 months)
  • Need for support(Change from baseline and to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoffer Johansen

Professor, DMSc

Danish Cancer Society

研究点 (1)

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