Measuring Stress in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer or Ductal Carcinoma In Situ of the Breast
NCT ID: NCT00665782
Last Updated: 2018-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
24 participants
OBSERVATIONAL
2008-03-31
2010-07-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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laboratory biomarker analysis
questionnaire administration
study of socioeconomic and demographic variables
assessment of therapy complications
psychosocial assessment and care
therapeutic conventional surgery
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Julia A. Lawrence
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Locations
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Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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CCCWFU-97307
Identifier Type: -
Identifier Source: secondary_id
IRB00004300
Identifier Type: -
Identifier Source: org_study_id
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