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临床试验/NCT05486754
NCT05486754已完成不适用

Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

University of Miami2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 1999年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
260
试验地点
2
主要终点
Change in Perceived Stress Management Abilities as measured by the Measure of Current Status Questionnaire

研究概览

简要总结

The purpose of this study is to test a stress management program for men with early-stage prostate cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Perceived Stress Management Abilities as measured by the Measure of Current Status Questionnaire

时间窗: Baseline, up to 18 months

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.

Change in immune cell percentage

时间窗: Baseline, up to 18 months

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.

Change in ratio of natural killer cell cytotoxicity as captured by Lytic Index

时间窗: Baseline, up to 18 months

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.

Change in post-traumatic event perceptions as measured by the Benefit Finding Scale questionnaire

时间窗: Baseline, up to 18 months

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.

Change in optimism as measured by the Life Orientation Test - Revised questionnaire

时间窗: Baseline, up to 18 months

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.

Change in count of natural killer cell cytotoxicity as captured by Kinetic Lytic Index

时间窗: Baseline, up to 18 months

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.

Change in natural killer cell percentage

时间窗: Baseline, up to 18 months

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.

Change in immune cell count

时间窗: Baseline, up to 18 months

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.

Change in natural killer cell count

时间窗: Baseline, up to 18 months

Natural killer cell (CD56+CD3-) count is evaluated from blood samples. Values are evaluated in count per cubic millimeter.

Change in natural killer cell cytotoxicity as captured by activity percentage

时间窗: Baseline, up to 18 months

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael H. Antoni

Professor

University of Miami

研究点 (2)

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