Educational Intervention for Reducing Work Disability in Breast Cancer Survivors
2019年11月14日 更新者：University of Wisconsin, Madison
Reducing Work Disability in Breast Cancer Survivors
This randomized clinical trial studies an educational intervention for reducing work disability in breast cancer survivors.
Web sites providing symptom management education may be an effective method to help breast cancer survivors reduce work disability after treatment
研究概览
地位
完全的
详细说明
PRIMARY OBJECTIVES:
I. Determine the feasibility and usability of the Work Ability Improvement Through Symptom Management and Ergonomic Strategies (WISE) and empirically evaluate its effect on short-term work ability among breast cancer survivors (BCS).
SECONDARY OBJECTIVES:
I. Explore individual and workplace factors associated with work ability in BCS.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive access to the WISE web-based educational intervention to help BCS manage their symptoms, identify ergonomic workplace problems and risks, and implement ergonomic modifications. Patients also receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
ARM II: Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
After completion of study treatment, patients are followed up at 3 and 6 months.
研究类型
介入性
注册 (实际的)
44
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
-
-
Wisconsin
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Madison、Wisconsin、美国、53792
- University of Wisconsin Hospital and Clinics
-
-
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
25年 至 64年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Diagnosed with breast cancer
- Employed at time of cancer diagnosis (defined as paid employment > 20 hours/week)
- Within six months of completion of active treatment
- Working during treatment or intending to return to work following active treatment
- Computer and internet access
Exclusion Criteria:
- Patients who do not intend to continue/resume working following treatment
- Develop distant metastases or progressive disease
- Prior diagnosis of malignancy at any other site except for in situ carcinomas of the cervix or non-melanomatous skin cancers
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 |
|---|---|
|
实验性的：Arm I (WISE)
Patients receive access to the WISE web-based educational intervention to help BCS manage their symptoms, identify ergonomic workplace problems and risks, and implement ergonomic modifications.
Patients also receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
|
辅助研究
辅助研究
其他名称：
Receive access to the WISE web-based educational intervention
Receive standard of care
其他名称：
Receive access to the WISE web-based educational intervention
其他名称：
|
|
有源比较器：Arm II (control)
Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
|
辅助研究
辅助研究
其他名称：
Receive standard of care
其他名称：
|
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 |
|---|---|---|
|
Usability of the WISE website as assessed by responses to a 5-point Likert scale
大体时间：3 months
|
The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.
|
3 months
|
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Usability of the WISE website as assessed by responses to a 5-point Likert scale
大体时间：6 months
|
The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.
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6 months
|
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Work ability, assessed by the Work Limitations Questionnaire (WLQ)
大体时间：Baseline
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Baseline
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Work ability, assessed by the WLQ
大体时间：3 months
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3 months
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Work ability, assessed by the WLQ
大体时间：6 months
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6 months
|
|
|
Individual factors, including symptoms assessed using the Symptom Bother-Revised scale (SB-R) and MD Anderson Symptom Inventory (MDASI), socio-demographic factors, individual disease factors, and treatment factors
大体时间：Baseline
|
Baseline
|
|
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Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
大体时间：3 months
|
3 months
|
|
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Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
大体时间：6 months
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6 months
|
|
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Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the Job Content Questionnaire (JCQ)
大体时间：Baseline
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Baseline
|
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Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
大体时间：3 months
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3 months
|
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Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
大体时间：6 months
|
6 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Feasibility measures, including participation/dropout rates, patient satisfaction, usability/satisfaction with WISE, knowledge/use of self-care symptom management/ergonomic strategies, and use of ergonomic/symptom management strategies, and barriers
大体时间：Up to 6 months
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Up to 6 months
|
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Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation
大体时间：Up to 6 months
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Up to 6 months
|
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Individuals self-reported work ability, using the Work Ability Index (WAI)
大体时间：Up to 6 months
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Up to 6 months
|
|
Employment status
大体时间：Up to 6 months
|
Up to 6 months
|
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Change in job performance or difficulty performing work tasks
大体时间：Baseline to 6 months
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Baseline to 6 months
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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：Mary Sesto、University of Wisconsin, Madison
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
2015年7月1日
初级完成 (实际的)
2015年10月1日
研究完成 (实际的)
2017年6月1日
研究注册日期
首次提交
2013年2月21日
首先提交符合 QC 标准的
2013年2月21日
首次发布 (估计)
2013年2月26日
研究记录更新
最后更新发布 (实际的)
2019年11月18日
上次提交的符合 QC 标准的更新
2019年11月14日
最后验证
2017年7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.