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 Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Stress Measures in Women With Newly Diagnosed Breast Cancer

Conditions
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Anxiety Disorder, Breast Cancer, Depression, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Other: questionnaire administration
* Other: study of socioeconomic and demographic variables
* Procedure: assessment of therapy complications
* Procedure: psychosocial assessment and care
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|nan|
|Other: questionnaire administration|nan|
|Other: study of socioeconomic and demographic variables|nan|
|Procedure: assessment of therapy complications|nan|
|Procedure: psychosocial assessment and care|nan|
|Procedure: therapeutic conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diurnal cortisol rhythm |  | Up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety disorder, depression, psychosocial effects of cancer and its treatment, ductal breast carcinoma in situ, breast cancer in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer