Correlation of Serum Catecholamine With Emotional Stress in Men With Prostate Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Change in perceived stress scores, assessed by the Self-Perceived Stress Questionnaire
研究概览
简要总结
This pilot research trial studies the collection of serum samples in studying emotional stress in patients with prostate cancer. Studying serum samples from patients with prostate cancer in the laboratory may help doctors determine if levels of epinephrine and cortisol, substances the body makes when stressed, rise or fall with how patients are feeling and/or if those levels are related to clinical information related to prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine if serum epinephrine or cortisol levels in men with prostate cancer correlate with perceived stress or distress over time in two to five consecutive visits.
SECONDARY OBJECTIVES:
I. To determine the change in serum epinephrine levels in men with prostate cancer over time in two to five consecutive visits.
II. To determine the change in serum cortisol levels in men with prostate cancer over time in two to five consecutive visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of prostate cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
- •Individuals able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document
排除标准
- •History of current or past medical or psychiatric illness that would make participation difficult or not feasible at the discretion of the principal investigator or co-investigators
结局指标
主要结局
Change in perceived stress scores, assessed by the Self-Perceived Stress Questionnaire
时间窗: Up to 1 year
Will calculate the patient's stress levels at each of the 5 visits using a validated measure of self-perceived stress
Change in serum cortisol levels
时间窗: Up to 1 year
Will calculate the change in serum cortisol levels between the first and last assessment and calculate the corresponding change in perceived stress or distress during the same time period. Will estimate the Pearson correlation between the two changes. Will also estimate a 95% confidence interval for this estimated correlation. These calculations will be performed overall (pooling all 3 groups together) and then repeated for each of the three groups of men separately. Will fit a longitudinal mixed model that incorporates the repeated measures taken on each patient. Additional int
Change in distress score, assessed by the Distress Thermometer
时间窗: Up to 1 year
Will calculate the patient's stress levels at each of the 5 visits using a validated distress thermometer
Change in serum epinephrine levels
时间窗: Up to 1 year
Will calculate the change in serum epinephrine levels between the first and last assessment and calculate the corresponding change in perceived stress or distress during the same time period. Will estimate the Pearson correlation between the two changes. Will also estimate a 95% confidence interval for this estimated correlation. These calculations will be performed overall (pooling all 3 groups together) and then repeated for each of the three groups of men separately. Will fit a longitudinal mixed model that incorporates the repeated measures taken on each patient. Additional int
次要结局
- Change in levels of distress assessed by the Distress Thermometer(Baseline up to 1 year)
- Change in serum cortisol levels(Baseline up to 1 year)
- Change in serum epinephrine levels(Baseline up to 1 year)
- Change in self-perceived stress, assessed by the Self-Perceived Stress Questionnaire(Baseline up to 1 year)