Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners (HIH)
2015年2月25日 更新者：Anne Nicolaisen、University of Southern Denmark
Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.
This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care
研究概览
详细说明
The intervention intends to improving the patient and partners well-being, quality of life and their relationship adjustment.
The couples in the intervention group participates i six to eight couple sessions. The sessions is conducted by an experienced psychologist and takes place one to five months after the patients cancer diagnosis. The control group receives usual care.
The framework of the intervention is attachment theory and the psychologists support and advise the couples in talking candidly about their feelings regarding their new life situation with cancer. The psychologist focus on the couples ability to feel comfortable and safe in each others presence.
研究类型
介入性
注册 (实际的)
198
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
-
-
-
Herlev、丹麦、2730
- Herlev University Hospital
-
Odense、丹麦、5000
- Odense University Hospital
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Ringsted、丹麦、4100
- Ringsted Hospital
-
-
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:
- Women newly diagnosed with a primary breast cancer (in the last 4 weeks)
- Women cohabiting with a male partner in a romantic relationship
- Patient and partner speaks and reads danish
Exclusion Criteria:
- Patients having a previous cancer diagnosis
- Neoadjuvant therapy for breast cancer
- Previous hospital admission with diagnosed psychotic episodes
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
|
|
|
实验性的：Psychological Intervention
|
Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.
|
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 |
|---|---|---|
|
Change in Impact of Event Scale (IES)
大体时间：Baseline, 2 weeks post-intervention, 10 months follow-up
|
IES assesses traumatic reactions to the breast cancer diagnosis.
Assessed by both patients and partners
|
Baseline, 2 weeks post-intervention, 10 months follow-up
|
|
Change in The Hospital Anxiety and Depression Scale (HADS)
大体时间：Baseline, 2 weeks post-intervention, 10 months follow-up
|
Assesses feelings of anxiety and depressive symptoms.
Assessed by both patients and partners.
|
Baseline, 2 weeks post-intervention, 10 months follow-up
|
|
Change in The Profile of Mood States - Short Form (POMS-SF)
大体时间：Baseline, 2 weeks post-intervention, 10 months follow-up
|
Assesses mood changes.
Assessed by both patients and partners
|
Baseline, 2 weeks post-intervention, 10 months follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Dyadic Adjustment Scale - Revised (DAS-R)
大体时间：Baseline, 2 weeks post-intervention, 10 months follow-up
|
Assesses relationship functioning and marital satisfaction.
Assesed by both patients and partners
|
Baseline, 2 weeks post-intervention, 10 months follow-up
|
|
Change in Relationship Questionnaire (RQ)
大体时间：Baseline, 2 weeks post-intervention, 10 months follow-up
|
RQ provides a profile of an individual's attachment feelings and behaviour.
Assessed by both patients and partners
|
Baseline, 2 weeks post-intervention, 10 months follow-up
|
|
Change in Functional Assessment of Cancer Therapy - Breast (FACT-B)
大体时间：Baseline, 2 weeks post-intervention and 10 months follow-up
|
Assesses health-related quality of life with additional questions for women dignosed with breast cancer.
|
Baseline, 2 weeks post-intervention and 10 months follow-up
|
|
Change in Functional Assessment of Cancer Therapy - general population (FACT-GP)
大体时间：Baseline, 2 weeks post-intervention and 10 months follow-up
|
Assesses health-related quality of life.
Assessed by partners
|
Baseline, 2 weeks post-intervention and 10 months follow-up
|
|
Change in Functional Assessment of Chronic Illness Therapy-Fatigue
大体时间：Baseline, 2 weeks post-intervention and 10 months follow-up
|
Assesses individual fellings of fatigue.
Assessed by the patients
|
Baseline, 2 weeks post-intervention and 10 months follow-up
|
|
Change in Post Traumatic Growth Inventory
大体时间：2-weeks post-intervention and 10 months follow-up
|
Assesses positive changes in individuals experiencing traumatic life events.
Assessed by both patients and partners
|
2-weeks post-intervention and 10 months follow-up
|
|
Change in EuroQol-5 Dimensions (EQ-5D)
大体时间：Baseline, 2 weeks post-intervention and 10 months follow-up
|
Assesses health-related quality of life.
Assessed by both patients and partners
|
Baseline, 2 weeks post-intervention and 10 months follow-up
|
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。
合作者
调查人员
- 首席研究员：Dorte G Hansen, PhD、University of Southern Denmark
- 学习椅：Mariët Hagedoorn, Professor、University of Groningen
- 学习椅：Christoffer Johansen, Professor、Danish Cancer Society
- 学习椅：Henrik Flyger, MD, Ph. D、University of Copenhagen
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。
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
2011年10月1日
初级完成 (实际的)
2013年8月1日
研究完成 (实际的)
2014年5月1日
研究注册日期
首次提交
2011年5月23日
首先提交符合 QC 标准的
2011年6月6日
首次发布 (估计)
2011年6月7日
研究记录更新
最后更新发布 (估计)
2015年2月26日
上次提交的符合 QC 标准的更新
2015年2月25日
最后验证
2015年2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.