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 |
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.
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).
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
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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