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Stress Measures in Women With Newly Diagnosed Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Anxiety Disorder, Breast Cancer, Depression, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

Stress Measures in Women With Newly Diagnosed Breast Cancer


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Diurnal cortisol rhythm

Safety Issue:

No

Principal Investigator

Julia A. Lawrence

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000586701

NCT ID:

NCT00665782

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Anxiety Disorder
  • Breast Cancer
  • Depression
  • Psychosocial Effects of Cancer and Its Treatment
  • 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
  • Anxiety Disorders
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Depression
  • Depressive Disorder

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096