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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00665782
First received: April 23, 2008
Last updated: May 30, 2017
Last verified: May 2017
April 23, 2008
May 30, 2017
March 2008
July 2010   (Final data collection date for primary outcome measure)
Diurnal cortisol rhythm [ Time Frame: Up to 10 days ]
Diurnal cortisol rhythm
Complete list of historical versions of study NCT00665782 on ClinicalTrials.gov Archive Site
  • Consistency of diurnal salivary cortisol levels over two days [ Time Frame: Up to 10 days ]
  • Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery [ Time Frame: 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 [ Time Frame: Up to 10 days ]
  • Consistency of diurnal salivary cortisol levels over two days
  • Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery
  • Correlation of the diurnal cortisol rhythm and the night-time urinary excretion with the measures of psychosocial and behavioral stress responses
Not Provided
Not Provided
 
Measuring Stress in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer or Ductal Carcinoma In Situ of the Breast
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).

Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Those diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the breast within the past 2 weeks
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00665782
CCCWFU 97307
P30CA012197 ( US NIH Grant/Contract Award Number )
CCCWFU-97307
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
Wake Forest University Health Sciences
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: Julia A. Lawrence Wake Forest University Health Sciences
Wake Forest University Health Sciences
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP