REBECCA - Research in Rehabilitation After Breast Cancer (REBECCA)
2015年8月5日 更新者:Christoffer Johansen、Danish Cancer Society
Optimized Rehabilitation: A Randomized Study of Systematic Monitoring and Management of Breast Cancer Patients' Symptoms
The purpose of this study is to examine if a psychosocial intervention including a nurse navigator and systematic symptom screening may reduce psychological and physical symptoms as well as health behavior after breast cancer.
研究概览
详细说明
In this pilot study with a randomized controlled trial design, we examine the effect of an intervention optimizing and integrating rehabilitation for breast cancer on psychological and physical symptoms as well as health behavior after breast cancer.
In the intervention group, we systematically screen for psychological and physical symptoms as well as health behavior (smoking alcohol and physical activity) not in line with the recommendations.
Patients who screen positive are offered a sequence of sessions with a navigator nurse who monitor rehabilitation needs, supports the patient, educate in self-management of symptoms and refer to existing rehabilitation services as well as to up to 6 free sessions with a psychologist specialized in cancer patients.
The rehabilitation services that the nurse refers to include several hospital departments and municipality services as well as general practice and by thorough follow-up on the patients use of these, the intervention aims at developing an integrated treatment and rehabilitation trajectory.
The control group receives standard care.
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Copenhagen、丹麦、2100
- Rigshospitalet
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- diagnosis of primary breast cancer at Breast Oncology Clinic, Rigshospitalet, Copenhagen, Denmark
- lives in Copenhagen municipality
- score ≥7 on distress thermometer
- able to read and understand Danish
- not pregnant
- expected survival more than 6 months
- physically able to participate in rehabilitation
- no severe psychiatric disease demanding treatment
- no severe cognitive problems (e.g. dementia or confusion)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:日常护理
|
|
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实验性的:Screening-based nurse navigation
Based on systematic screening for psychological and physical symptoms as well as health behavior a nurse navigator will refer to and monitor use of appropriate rehabilitation programs
|
Screening-based nurse navigation for breast cancer rehabilitation
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Psychological distress
大体时间:6 and 12 months
|
Difference in change in psychological distress between patients in the intervention and control group.Psychological distress wil be measured using the Distress Thermometer
|
6 and 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Health related quality of life
大体时间:6 and 12 months
|
Difference in change in patient reported health related quality of life between patients in the intervention and control group.
Health related quality of life will be measured using the European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC QLQ C30 and the EORTC BR23 including subscales.
|
6 and 12 months
|
|
Anxiety and depression
大体时间:6 and 12 months
|
Difference in change in patient reported anxiety and depression between patients in the intervention and control group.
Anxiety and depresison will be measured using the Hospital Anxiety and Depression scale (HADS).
|
6 and 12 months
|
|
Smoking
大体时间:6 and 12 months
|
Difference in change in patient reported cigarette smoking measured in grams per day between patients in intervention and control group.
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6 and 12 months
|
|
Alcohol consumption
大体时间:6 and 12 months
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Difference in change in patient reported alcohol consumption measured in grams per day between patients in intervention and control group.
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6 and 12 months
|
|
Body mass index
大体时间:6 and 12 months
|
Difference in change in patient reported body masss index between patients in intervention and control group.
|
6 and 12 months
|
|
Physical activity
大体时间:6 and 12 months
|
Difference in change in patient reported physical activity between patients in intervention and control group.
|
6 and 12 months
|
|
Use of rehabilitation services
大体时间:6 and 12 months
|
Difference in change in patient reported use of rehabilitation services between patients in intervention and control group.
|
6 and 12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Christoffer Johansen, MD, Phd、Danish Cancer Society
- 首席研究员:Pernille E Bidstrup, MA. PhD、Danish Cancer Society
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年7月1日
初级完成 (实际的)
2015年7月1日
研究完成 (实际的)
2015年7月1日
研究注册日期
首次提交
2014年2月5日
首先提交符合 QC 标准的
2014年2月5日
首次发布 (估计)
2014年2月6日
研究记录更新
最后更新发布 (估计)
2015年8月7日
上次提交的符合 QC 标准的更新
2015年8月5日
最后验证
2015年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.