Measuring Stress in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer or Ductal Carcinoma In Situ of the Breast

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00665782

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorder Breast Cancer Depression Psychosocial Effects of Cancer and Its Treatment	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

Detailed Description

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).

Study Design

Study Type:

Observational

Actual Enrollment :

24 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Stress Measures in Women With Newly Diagnosed Breast Cancer

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Outcome Measures

Primary Outcome Measures

Diurnal cortisol rhythm [Up to 10 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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