Stress Management in Breast Cancer Patients
2015年12月3日 更新者：Uppsala University
How Can Health Care Help Female Breastcancer Patients Reduce Their Stress Symptoms? A Randomized Intervention Study With Stepped-care
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.
研究概览
研究类型
介入性
注册 (实际的)
466
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
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-
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Falun、瑞典
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Gävle、瑞典
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Uppsala、瑞典
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-
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:
- over the age of 18
- a recent diagnosis of breast cancer
- scheduled for adjuvant treatment in Falun, Gävle or Uppsala (Sweden)
Exclusion Criteria:
- ongoing psychiatric condition
- language deficiencies in Swedish
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：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 |
|---|---|
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实验性的：Stress management Individual format
The methods and techniques will be the same as those used in the group intervention.
The first session will be used for a detailed assessment of the individual's psychosocial problems, as used in earlier studies.
The sessions will last 45 - 60 minutes.
The number of sessions will depend on the individual patient's problems and the joint assessment made by the patient and nurse together.
The total number of sessions will be at least 4, with a maximum of 8.
The contents of the sessions are Session 1: Assessment, Session 2: Analysis of diary (self-registration) and suggestions for problem management, Session 3: Evaluation of problem management skills Session 4: Follow-up and conclusion of the intervention.
When necessary Sessions 5 -8 will address specific obstacles and continued practice.
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All patients start at the first step of the intervention program with a two hours psychoeducation in stress management.
Patients, who don't report a decrease in stress related symptoms, after the first step will be offered an intensive stress management, either in individual or group format.
Components included in the intervention concern 1) basic knowledge about cancer, treatment, healthy living and stress reactions, 2) self-awareness with help of diary for thoughts, feelings and behavior 3) instruction in various techniques on how to express negative feelings, how to communicate with others more effectively, how to change behaviors related to stress 4) training these techniques in real-life situations 5) cognitive restructuring 6) spirituality, derived from cognitive behavior therapy.
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实验性的：Stress management Group format
Participants will meet for 2 hours every week for a total of 20 hours.
In the intervals between the group meetings patients will be asked to do homework.
Homework entails practicing problem-solving techniques, keeping a diary, practicing relaxation or physical activities.
Each group meeting has a specific subject, i.e.
What is stress and stress behaviors, Stress related symptoms, How to manage anger and negative thoughts, Self-registrations and behavioral changes, Future perspectives, Cancer, stress and relations, Expectations and demands, Body, pleasure and sexuality.
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All patients start at the first step of the intervention program with a two hours psychoeducation in stress management.
Patients, who don't report a decrease in stress related symptoms, after the first step will be offered an intensive stress management, either in individual or group format.
Components included in the intervention concern 1) basic knowledge about cancer, treatment, healthy living and stress reactions, 2) self-awareness with help of diary for thoughts, feelings and behavior 3) instruction in various techniques on how to express negative feelings, how to communicate with others more effectively, how to change behaviors related to stress 4) training these techniques in real-life situations 5) cognitive restructuring 6) spirituality, derived from cognitive behavior therapy.
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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 |
|---|---|---|
|
Psychosocial aspect
大体时间：Changes in psychosocial aspects from baseline to 12 months post diagnosis
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Intrusion, Avoidance, Anxiety, Depression, Quality of life, Fatigue, Daily stress
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Changes in psychosocial aspects from baseline to 12 months post diagnosis
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Cost-Utility Analysis
大体时间：12 month
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12 month
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Patient satisfaction
大体时间：3 month, after intensive intervention and 12 month
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3 month, after intensive intervention and 12 month
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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：Karin Nordin, Prof、Uppsala University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Hellerstedt-Borjesson S, Nordin K, Fjallskog ML, Holmstrom IK, Arving C. Women Treated for Breast Cancer Experiences of Chemotherapy-Induced Pain: Memories, Any Present Pain, and Future Reflections. Cancer Nurs. 2016 Nov/Dec;39(6):464-472. doi: 10.1097/NCC.0000000000000322.
- Nordin K, Rissanen R, Ahlgren J, Burell G, Fjallskog ML, Borjesson S, Arving C. Design of the study: how can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care. BMC Cancer. 2012 May 4;12:167. doi: 10.1186/1471-2407-12-167.
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
2009年5月1日
初级完成 (实际的)
2014年3月1日
研究完成 (实际的)
2014年9月1日
研究注册日期
首次提交
2012年2月28日
首先提交符合 QC 标准的
2012年3月14日
首次发布 (估计)
2012年3月15日
研究记录更新
最后更新发布 (估计)
2015年12月4日
上次提交的符合 QC 标准的更新
2015年12月3日
最后验证
2015年12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.