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



Status:Completed
Conditions:Anxiety, Breast Cancer, Cancer, Cancer, Depression, Psychiatric
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 120
Updated:7/5/2018
Start Date:March 2008
End Date:July 2010

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Stress Measures in Women With Newly Diagnosed Breast Cancer

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.

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).

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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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mi
from
Winston-Salem, NC
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