Clinical trial NCT00665782: Measuring Stress in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer or Ductal Carcinoma In Situ of the Breast
Official title: Stress Measures in Women With Newly Diagnosed Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety Disorder
Breast Cancer
Depression
Psychosocial Effects of Cancer and Its Treatment
Keywords: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the breast within the past 2 weeks

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Diurnal cortisol rhythm
timeFrame: Up to 10 days
Secondary outcomes:
measure: Consistency of diurnal salivary cortisol levels over two days
timeFrame: Up to 10 days
measure: Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery
timeFrame: Up to 10 days
measure: Correlation of the diurnal cortisol rhythm and the night-time urinary excretion with the measures of psychosocial and behavioral stress responses
timeFrame: Up to 10 days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Julia A. Lawrence
role: STUDY_CHAIR
References: