Expired Study
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Winston-Salem, North Carolina 27157


Purpose:

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.


Study summary:

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). OUTLINE: Patients are stratified according to race (Caucasian vs African American). Patients are instructed to collect saliva and urine samples on 2 separate days, within 2 weeks of study enrollment. Saliva samples are collected 6 times a day at baseline, before breast cancer surgery, and 7-10 days after surgery. Urine samples are collected after midnight until and including the first morning sample on the saliva-collection days. Patients also complete questionnaires (either by telephone interview or in person) within 2 weeks of study enrollment and 7-10 days after breast surgery. Stress measures examined include optimism (LOT-R), trait-anxiety scale (STAI form Y-2), functional social support, affect and depression (PANAS and CES-D), perceived stress (PSS-10), economic hardship scales, discrimination (EOD), coping mechanisms (Brief COPE), and dietary fat consumption (Block Sugar/Fat/Fruit/Vegetable screener).


Criteria:

Inclusion Criteria: - 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 - Female - 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


NCT ID:

NCT00665782


Primary Contact:

Study Chair
Julia A. Lawrence
Wake Forest University Health Sciences


Backup Contact:

N/A


Location Contact:

Winston-Salem, North Carolina 27157
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 16, 2018

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