NCT00665782已完成不适用
Stress Measures in Women With Newly Diagnosed Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Diurnal cortisol rhythm
研究概览
简要总结
RATIONALE: Gathering information about how patients respond to stress and measuring stress levels in women with newly diagnosed breast cancer may help doctors provide better methods of treatment and on-going care.
PURPOSE: This research study is measuring stress in women with newly diagnosed stage I, stage II, or stage III breast cancer or ductal carcinoma in situ of the breast.
详细描述
OBJECTIVES:
Primary
- Describe the distributions of physiologic, psychosocial, and behavioral response to stress in women with newly diagnosed breast cancer.
- Describe the patterns of diurnal cortisol rhythms in women newly diagnosed with breast cancer.
Secondary
- Determine if diurnal salivary cortisol (mean or pattern) is consistent over two days within two weeks of study entry.
- Assess the changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion change after an intervening stress event (pre- to post-surgery).
- Determine if the diurnal cortisol rhythm and the night-time urinary excretion correlate with a variety of self-reported psychosocial factors: optimism (LOT-R), state and trait anxiety (STAI form Y-2), positive and negative affect (PANAS), depressive symptoms (CES-D), coping (Brief COPE), and perceived stress (PSS-10).
- Determine if the diurnal cortisol rhythm and the night-time urinary epinephrine excretion correlate with socioeconomic stress and discrimination (functional social support and discrimination [EOD]).
- Determine if the diurnal cortisol rhythm and the night-time urinary epinephrine excretion correlate with one lifestyle behavior and dietary fat consumption (Block food screener).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the breast within the past 2 weeks
- •Surgery for breast cancer planned
- •Hormone receptor status not specified
- •Menopausal status not specified
- •Able to refrain from:
- •Smoking cigarettes for the 24-hour period of saliva-sample collection
- •Brushing teeth or eating for up to one hour prior to saliva collection
- •More than 1 year since prior therapy for another malignancy
- •At least 1 month since prior withdrawal from hormone-replacement product
- •Able to refrain from steroid inhalers for greater than 24 hours
- •No chronic oral steroids
排除标准
- 未提供
结局指标
主要结局
Diurnal cortisol rhythm
时间窗: Up to 10 days
次要结局
- Consistency of diurnal salivary cortisol levels over two days(Up to 10 days)
- Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery(Up to 10 days)
- Correlation of the diurnal cortisol rhythm and the night-time urinary excretion with the measures of psychosocial and behavioral stress responses(Up to 10 days)
研究者
研究点 (1)
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