A Survey of Sleep Problems in Survivors of Breast Cancer
研究概览
地位
条件
详细说明
Individuals who consent to participate in this study will be asked to complete a battery of questionnaires that will take approximately 1 hour. Based on answers they give to the questionnaires, 45 patients will be asked to participate in a sleep study done at a sleep lab.
If you choose to take part, then you will be asked to do the following:
Spend approximately 1 hour answering questionnaires either at the breast cancer center with a research assistant, at home on the phone with a research assistant, or by completing the questionnaires at home and returning them by mail. You will only be asked to complete questionnaires one time. The questionnaires will ask you questions about your:
- Past medical history
- Demographics
- Sleep quality
- Sleep habits
- Energy level, pain, daytime sedation
- Quality of life
- Menopausal symptoms
- Depression
- Fears
If you are then selected to participate in the sleep study, further information will be provided for you.
After you are finished with the questionnaires, the research assistant will provide you with any necessary further information and feedback. The research assistant will also be able to put you in contact with a study doctor should you require any further assistance. After you are finished with the study, the study doctor may contact you for clarification of your answer on a question, or for an answer if you have by any chance missed a question.
研究类型
注册 (实际的)
联系人和位置
学习地点
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New York
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New York、New York、美国、10021
- Memorial Sloan Kettering Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
Subject Inclusion Criteria for Questionnaire Portion of Study
- Women with a diagnosis of Stage I, II, or III breast cancer who are one year posttreatment, but not more than 10 years post-treatment (surgery, chemotherapy, and/or radiation) prior to entrance into the study. Use of biological and/or hormonal therapy is acceptable.
- Greater than 18 years of age.
- Able to speak and read English.
Exclusion Criteria:
Subject Exclusion Criteria for Questionnaire Portion of Study •Evidence of acute or chronic encephalopathy or psychiatric disease severe enough to compromise data collection.
Exclusion Criteria for Sleep Lab Study
•Women who are unable or unwilling to avoid alcohol, caffeine consumption or cigarette smoking as of 3 p.m. on the day of the sleep study.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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1
15 subjects with subjective sleep disturbance based on the Pittsburgh Sleep Quality Index
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2
mild/moderate subjective sleep disturbance (insomnia) based on the Pittsburgh Sleep Quality Index
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3
severe subjective sleep disturbance (insomnia)based on the Pittsburgh Sleep Quality Index
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Determine the prevalence of cancer-related insomnia in women surviving breast cancer (Stage I, II, & III) who are at least one year, but not more than 10 years posttreatment & to study its deleterious impact on qol
大体时间：2 years
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2 years
|
|
To describe the underlying physiology and nature of sleep disturbances in this cohort of women by performing sleep lab studies with a subset of the sample
大体时间：2 years
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2 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
To survey the medical, demographic and psychosocial correlates of cancer-related insomnia in this cohort of women to identify subgroups with potentially differing etiologies and associated symptoms to help plan relevant intervention studies
大体时间：2 Years
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2 Years
|
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To preliminarily describe correlations between subgroups and sleep disturbances documented in the sleep lab studies
大体时间：2 years
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2 years
|
合作者和调查者
调查人员
- 首席研究员：Steven Passik, PhD、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.