Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer
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
- 否
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
Michael H. Antoni
Professor
University of Miami
