Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer
2022年8月2日 更新者：Michael H. Antoni、University of Miami
The purpose of this study is to test a stress management program for men with early-stage prostate cancer.
研究概览
研究类型
介入性
注册 (实际的)
260
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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Florida
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Miami、Florida、美国、33136
- University of Miami
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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
50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
男性
描述
Inclusion criteria:
- Men who had undergone either a radical prostatectomy or radiation therapy (i.e., external beam or seed implant) for stage I or II prostate cancer in the preceding 18-months
- 50 years of age or older
- Ability to speak, read, and write in English
- Having a ninth grade reading level or greater
- Being free of cognitive impairment that would interfere with the study
- No active psychiatric symptoms in the previous three months.
Exclusion criteria:
- Previous history of non-skin cancer
- Have received adjuvant treatment, including hormone treatment, for prostate cancer
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 |
|---|---|
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实验性的：Cognitive behavioral stress management group
Participants received the cognitive behavioral stress management intervention for 10 weeks.
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Participants will receive in-person weekly stress management group sessions (3-8 participants) for two hours per week for ten weeks total.
Each session will consist of a half hour of relaxation training and one and a half hours of stress management skill training, including coping effectiveness training, anger management, assertiveness training, and stress awareness.
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有源比较器：Health promotion group
Participants received the health promotion group for one day.
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Participants will receive one four-hour seminar in-person groups (3-8 participants) of educational information related to prostate cancer and abbreviated psychological information provided in cognitive behavioral stress management.
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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 |
|---|---|---|
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Change in Perceived Stress Management Abilities as measured by the Measure of Current Status Questionnaire
大体时间：Baseline, up to 18 months
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The Measure of Current Status questionnaire is a 23-item questionnaire each scored on a range of 0-4.
The total score ranges from 0-92 with the higher score corresponding to greater perceived abilities.
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Baseline, up to 18 months
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Change in post-traumatic event perceptions as measured by the Benefit Finding Scale questionnaire
大体时间：Baseline, up to 18 months
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The Benefit Finding Scale questionnaire is a 17-item measure capturing perception of a traumatic event (e.g., cancer diagnosis for participants) with each item scored on a scale of 1 to 5. The total score ranges from 17-85 with the higher score corresponding to greater perceived benefit.
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Baseline, up to 18 months
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Change in optimism as measured by the Life Orientation Test - Revised questionnaire
大体时间：Baseline, up to 18 months
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The Life Orientation Test - Revised questionnaire measures participant's optimism.
The total score ranges from 0-24 with the higher score corresponding to greater levels of optimism.
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Baseline, up to 18 months
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Change in immune cell count
大体时间：Baseline, up to 18 months
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Immune cell count (including T-cell (Cluster of Differentiation (CD) 3+) and T-helper cells (CD 3+ CD 4+) will be evaluated from blood samples.
Both values will be evaluated in count per cubic millimeter.
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Baseline, up to 18 months
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Change in immune cell percentage
大体时间：Baseline, up to 18 months
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Immune cell percentage (including T-cell (Cluster of Differentiation (CD) 3+) and T-helper cells (CD 3+ CD 4+) will be evaluated from blood samples.
Both values evaluated in count per cubic millimeter over total cell count per cubic millimeter.
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Baseline, up to 18 months
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Change in natural killer cell percentage
大体时间：Baseline, up to 18 months
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Natural killer cell (CD56+CD3-) percentage is evaluated from blood samples.
Values are evaluated in count per cubic millimeter over total cell count per cubic millimeter.
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Baseline, up to 18 months
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Change in natural killer cell count
大体时间：Baseline, up to 18 months
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Natural killer cell (CD56+CD3-) count is evaluated from blood samples.
Values are evaluated in count per cubic millimeter.
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Baseline, up to 18 months
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Change in natural killer cell cytotoxicity as captured by activity percentage
大体时间：Baseline, up to 18 months
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Natural killer cell (CD56+CD3-) cytotoxicity is evaluated from blood samples.
Cells are stimulated through exposure to a reactive cell line and the percentage of cells active are counted and divided by total cells present per cubic millimeter.
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Baseline, up to 18 months
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Change in ratio of natural killer cell cytotoxicity as captured by Lytic Index
大体时间：Baseline, up to 18 months
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Natural killer cell (CD56+CD3-) cytotoxicity is evaluated from blood samples.
Cells are stimulated through exposure to a reactive cell line and quantified as the ratio of responsive to unresponsive cells required to kill 10% of the target cell line.
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Baseline, up to 18 months
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Change in count of natural killer cell cytotoxicity as captured by Kinetic Lytic Index
大体时间：Baseline, up to 18 months
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Natural killer cell (CD56+CD3-) cytotoxicity is evaluated from blood samples.
Cells are stimulated through exposure to a reactive cell line and incubated for four hours total.
Kinetic lytic index is quantified as the count of targeted cells killed during incubation.
An average count of these cells will be calculated.
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Baseline, up to 18 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：Michael H Antoni, Ph.D.、University of Miami
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
- Penedo FJ, Molton I, Dahn JR, Shen BJ, Kinsinger D, Traeger L, Siegel S, Schneiderman N, Antoni M. A randomized clinical trial of group-based cognitive-behavioral stress management in localized prostate cancer: development of stress management skills improves quality of life and benefit finding. Ann Behav Med. 2006 Jun;31(3):261-70. doi: 10.1207/s15324796abm3103_8.
- Traeger L, Penedo FJ, Benedict C, Dahn JR, Lechner SC, Schneiderman N, Antoni MH. Identifying how and for whom cognitive-behavioral stress management improves emotional well-being among recent prostate cancer survivors. Psychooncology. 2013 Feb;22(2):250-9. doi: 10.1002/pon.2074. Epub 2011 Sep 19.
- Molton IR, Siegel SD, Penedo FJ, Dahn JR, Kinsinger D, Traeger LN, Carver CS, Shen BJ, Kumar M, Schneiderman N, Antoni MH. Promoting recovery of sexual functioning after radical prostatectomy with group-based stress management: the role of interpersonal sensitivity. J Psychosom Res. 2008 May;64(5):527-36. doi: 10.1016/j.jpsychores.2008.01.004.
- Walsh EA, Antoni MH, Popok PJ, Moreno PI, Penedo FJ. Effects of a randomized-controlled trial of cognitive behavioral stress management: Psychosocial adaptation and immune status in men with early-stage prostate cancer. Gen Hosp Psychiatry. 2022 Nov-Dec;79:128-134. doi: 10.1016/j.genhosppsych.2022.10.012. Epub 2022 Oct 27.
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 (实际的)
1999年6月22日
初级完成 (实际的)
2006年8月3日
研究完成 (实际的)
2006年8月3日
研究注册日期
首次提交
2022年8月2日
首先提交符合 QC 标准的
2022年8月2日
首次发布 (实际的)
2022年8月4日
研究记录更新
最后更新发布 (实际的)
2022年8月4日
上次提交的符合 QC 标准的更新
2022年8月2日
最后验证
2022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.